Regulatory Affairs – Interview Questions

1. What Is Regulatory Affairs?

Regulatory Affairs in a Pharmaceutical industry, is a profession which acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world.  It is mainly involved in the registration of the drug products in respective countries prior to their marketing.

1. What Are The Goals Of Regulatory Affairs (RA) Professionals?

The main goal of RA

• Protection of human health
• Ensuring safety, efficacy and quality of drugs
• Ensuring appropriateness and accuracy of product information.

1. What Are The Roles Of Regulatory Affairs Professionals?

The main role of RA Professionals:

• Act as a liaison with regulatory agencies.
• Preparation of organized and scientifically valid NDA, ANDA, INDA, MAA, DMF submissions.
• Ensure  adherence  and  compliance  with  all  the  applicable  cGMP,  ICH,  GCP,  GLP  guidelines, regulations and laws.
• Providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans.
• Advising the companies on regulatory aspects and climate that would affect their proposed activities.
• Apart from the above main roles, there are various other roles which Regulatory Affairs professionals play.
• Keeping  track  of  the  ever-changing  legislation  in  all  the  regions  in  which  a  company  wishes  to distribute its products.
• Advising on legal and scientific restraints and requirements.
•  Collecting, collating and evaluating scientific data.
• Presenting   registration   documents   to   regulatory   agencies   and   carrying   out   any   subsequent negotiations necessary to obtain or maintain marketing authorisation for the products concerned.
• Giving strategic and technical advice at the highest level in their companies, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole.
• Helping the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data.

1. What is an investigational: New Drug (ind) Application?

It‘s application which is filed with FDA to get approval for legally testing an experimental drug on human

subjects in the USA.

1. What is a new drug application (NDA)?

The  NDA  is  the  vehicle  through  which  drug  sponsors  formally  propose  that  the  FDA  approve  a  new

pharmaceutical for sale and marketing in the U.S.  The data gathered during the animal studies and human clinical trials of an Investigational new drug become part of the NDA.

In simple words, ―It is an application which is filed with FDA to market a new Pharmaceutical for sale in

USA‖.

1. What Are The Chemical Classification Codes For NDA?

• New molecular entity (NME)
• New ester, new salt, or other non-covalent derivative
• New formulation
• New combination
• New manufacturer
• New indication
• Drug already marketed, but without an approved NDA
• OTC (over-the-counter) switch

1. What Is An Abbreviated New Drug Application (ANDA)?

It is an application filed with FDA, for a U.S. generic drug approval for an existing licensed medication or

approved drug. In simple words, ―It is an application for the approval of Generic Drugs ―

1. What Is A Generic Drug Product?

A  generic  drug  product  is  the  one  that  is  comparable  to  an  innovator  drug  product  in  dosage  form,

strength, route of administration, quality, performance characteristics and intended use.

1. What Is A DMF?

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used

to   provide   confidential   detailed   information   about   facilities,   processes,   or   articles   used   in   the manufacturing, processing, packaging, and storing of one or more human drugs.

Important facts regarding DMFs:

•  It is submitted to FDA to provide confidential information
• Its submission is not required by law or regulations
• It is neither approved nor disapproved
• It is filed with FDA to support NDA, IND, ANDA another DMF or amendments and supplements to any of these
•  It is provided for in the 21 CFR (Code of Federal Regulations) 314. 420
• It is not required when applicant references its own information.

1. What Are the Types of DMF’S?

• Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel (No longer accepted by FDA)
• Type II: Drug Substance, Drug Substance  Intermediate, and Material Used in Their Preparation, or
• Drug Product
• Type III: Packaging Material
• Type IV : Excipient, Colorant, Flavour, Essence, or Material Used in Their Preparation
• Type V: FDA Accepted Reference Information (FDA discourages its use)

1. What is A 505 (b)(2) Application ?

505 (b)(2) application is a type of NDA for which one or more investigations relied on by applicant for

approval  were  not  conducted  by/for  applicant  and  for  which  applicant  has  not  obtained  a  right  of reference.

1. What Kind Of Application Can Be Submitted As A 505(b)(2) Application?

• New chemical entity (NCE)/new molecular entity (NME)
• Changes to previously approved drugs

1. What Are   The   Examples   Of   Changes   To   Approved   Drug   Products   For   Which   505(b)(2) Application Should Be Submitted ?

Change in dosage form.

• Change in strength.
• Change in route of administration.
• Substitution of an active ingredient in a formulation product.
• Change in formulation.
• Change in dosing regimen.
• Change in active ingredient.
• New combination Product.
• New indication.
• Change from prescription indication to OTC indication.
• Naturally derived or recombinant active ingredient.
• Bioinequivalence.

1. What Are The Differences Between NDA And 505 (b)(2) Application?

SN  New Drug Application (NDA)

1. All investigations  relied  on  by  applicant for      approval    were    conducted    by/for applicant and for which applicant has right

of reference

505 (b)(2) Application

One  or  more  investigation  relied  on  by  applicant for  approval  were  not  conducted  by/for  applicant and for which applicant has not obtained a right of reference

1. Generally, filed    for    newly    invented pharmaceuticals.

Generally, filed for new dosage form, new route of administration,  new  indication  etc  for  all  already approved pharmaceutical.

1. What Is A Marketing Authorization Application (MAA)?

It is  an  application filed  with the relevant  authority in the Europe (typically, the  UK’s  MHRA or the

EMA‘s Committee for Medicinal Products for Human Use (CHMP)) to market a drug or medicine. As per UK‘s MHRA-

• Applications for new active substances are described as ‘full applications’.
• Applications  for  medicines  containing  existing  active  substances  are  described  as  ‘abbreviated‘  or ‗abridged applications‘.

1. What Is An ASMF?

Active substance master file (ASMF) is a submission which is made to EMA, MHRA or any other Drug

Regulatory  Authority  in  Europe  to  provide  confidential  intellectual  property  or  ‘know-how’  of  the manufacturer of the active substance.

In  simple  words,  ―It  is  a  submission  made to  European  Drug regulatory agencies  on  the  confidential

information of Active Substance or Active pharmaceutical Ingredient (API)‖.

1. What Are The Types Of Active Substances For Which ASMFS Are Submitted?

• New active substances
• Existing   active   substances   not   included   in   the   European   Pharmacopoeia   (Ph.   Eur.)   or   the pharmacopoeia of an EU Member State
• Pharmacopeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State

1. What Is The Difference Between DMF & ASMF (with Respect To Submission)?

ASMF is submitted as Applicant‘s Part (Open Part) and Restricted Part (Closed Part). There isn‘t any differentiation of DMF‘s into parts

DMF

A    Drug    Master    File    (DMF)    is    a submission    to    the    Food    and    Drug Administration  (FDA)  that  may  be  used to       provide       confidential       detailed information about facilities, processes, or articles    used    in    the    manufacturing, processing, packaging, and storing of one or more human drugs.

ASMF

Active  substance  master  file  (ASMF)  is  a  submission which   is   made   to   EMA,   MHRA   or   any   other   Drug Regulatory  Authority  in  Europe  to  provide  confidential intellectual property or ‘know-how’ of the manufacturer of the active substance.

In  simple  words,  ―It  is  a  submission  made  to  European Drug  regulatory  agencies  on  the  confidential  information of  Active  Substance  or  Active  pharmaceutical  Ingredient (API)‖.

1. What Is ICH?

Active  substance  master  file  (ASMF)  is  a  submission which   is   made   to   EMA,   MHRA   or   any   other   Drug Regulatory  Authority  in  Europe  to  provide  confidential intellectual property or ‘know-how’ of the manufacturer of the active substance.

In  simple  words,  ―It  is  a  submission  made  to  European Drug  regulatory  agencies  on  the  confidential  information of  Active  Substance  or  Active  pharmaceutical  Ingredient (API)‖.

International    Conference    on    Harmonisation    of    Technical    Requirements    for    Registration    of Pharmaceuticals  for  Human  Use  (ICH):  is  a  project  that  brings  together  the  regulatory  authorities  of Europe,  Japan  and  the  United  States  and  experts  from  the  pharmaceutical  industry  in  the  three regions to discuss scientific and technical aspects of pharmaceutical product registration.

1. What are the ICH Guidelines to be Referred for Preparation of Registration Dossiers/applications

Of Medicines (with Respect To Format and Contents In Each Module)?

• M4   Guideline
• M4Q Guideline
• M4S Guideline
• M4E Guideline

1. What Is CTD?

The  Common  Technical  Document  (CTD)  is  a  set  of  specification  for  application  dossier,  for  the registration of Medicines and designed to be used across Europe, Japan and the United States. Quality, Safety  and  Efficacy  information  is  assembled  in  a  common  format  through  CTD  .The  CTD  is maintained   by   the   International   Conference   on   Harmonization   of   Technical   Requirements   for Registration of Pharmaceuticals for Human Use (ICH).

CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia etc.

1. What Are The Modules In CTD?

• The Common Technical Document is divided into five modules:
• Module 1 : Administrative information and prescribing information
• Module 2 :Common Technical Document summaries (Overview and summary of modules 3 to 5)
• Module 3 : Quality
• Module 4 : Nonclinical Study Reports (toxicology studies)
• Module 5 : Clinical Study Reports (clinical studies)

1. What Are The Procedures For Approval Of Drug In EU?

• Centralised Procedure (CP)
• Decentralised Procedure (DCP)
• Mutual Recognition Procedure (MRP)
• National Procedure (NP)

1. What Is The Full Form Of Abbreviation, CEP?

Certificate  of  Suitability  to  the  monographs  of  the  European  Pharmacopoeia  (or)  Certificate  of

suitability of monographs of the European Pharmacopoeia (or) Certification of suitability of European

Pharmacopoeia monographs

It is also informally referred to as Certificate of Suitability (COS)

1. What Is A CEP?

It is the certificate which is issued by Certification of Substances Division of European Directorate for

the Quality of Medicines (EDQM), when the manufacturer of a substance provides proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia.

1. What is dossier in regulatory affairs?

Regulatory      Dossier means      all regulatory documents      and      filings      registered      with      a

Drug Regulatory Authority for a Marketing Authorisation containing the administrative, safety, efficacy, quality, non-clinical and clinical data and CMC data for the Drug Product as it may change from time to time.

1. What are medical device regulatory affairs?

Regulatory affairs is a profession developed from the desire of governments to protect public health by

controlling   the   safety   and   efficacy  of   products   in   areas   including   pharmaceuticals,   veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies.

1. What does regulatory framework mean?

Regulatory  Framework  means any  laws, regulations,  decrees  and  policies  officially  developed  and

approved  by the  government,  for the purposes of regulating SOLID  WASTE generation, collection, transport, recycling, reuse, treatment and disposal.

1. What is a regulatory process?

The Regulatory Process. What is a regulation? Regulations, or rules, are a primary vehicle with which

agencies  implement  specific  laws  and  general  agency  objectives.  They  are  specific  standards  or instructions   concerning   what   can   or   cannot   be   done   by   individuals,   businesses,   and   other organizations.

1. What are regulatory standards?

Definition      of Regulatory      Standards:      Regulatory      Standards means      all      laws,      rules,

regulations and Regulatory Authority  advisory  opinions  or  orders  applicable  to  the  manufacturing, marketing, sale, reimbursement and/or pricing of any Products.

1. What are the statutory and regulatory requirements?

Both statutory  requirements and regulatory  requirements are  those requirements  that  are  required  by

law. … ―Statutory refers to laws passed by a state and/or central government, while regulatory refers to a rule issued by a regulatory body appointed by a state and/or central government.‖

1. What is the purpose of regulatory compliance?

In  general, compliance means  conforming  to  a  rule,  such  as  a  specification,  policy,  standard  or

law. Regulatory compliance describes  the goal that  organizations  aspire  to  achieve  in  their  efforts  to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations.

1. What are regulatory affairs in pharmaceutical industry?

Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries,

such as pharmaceuticals,  medical devices,  energy,  and banking.  … Pharmaceutical  companies use all the data accumulated during discovery and development stages in order to register the drug and thus market the drug.

1. What is Pharma ROW market?

United States (US) and the EU are the biggest and the most potential markets for in the world and are

categorized  under  the  regulated markets,  whereas ROW (Rest  of  the  World) market includes  all  the emerging markets like Brazil (LATAM), Tanzania (Africa), Russia (CIS), Hong Kong (ASIA), etc.

1. Why do we need regulatory affairs?

The main objective of regulatory affairs is to provide the basis for the assurance of high quality of food

products which can increase consumer’s interest for ensuring the efficacy, quality, and safety.

1. What is regulated drug?

Answer  and  Explanation:  A regulated  drug is  one  that  is  researched,  manufactured,  distributed,  and

administered under the supervision of regulatory authorities and/or..

1. What is dossier in regulatory affairs?

A collection of papers giving detailed information about particular person or subject.

Dossier and Regulatory Affairs:

Dossier helps,

• To create, assemble, update and publish a composite document(s) from various individual document sources and formats.
• Each document or sub dossier follows its own lifecycle.

1. What is the difference between CTD and Actd?

The ACTD consists of Parts I to IV which have subsections A to F whereas ICH-CTD has 5 Modules

with subsections that are numbered. The administrative data of Part I is part of ACTD whereas Module

1 of ICH-CTD is purely country specific.

1. What is dossier preparation?

Abstract: Dossier is   a   collection   of   documents   on   the   particular   subjects.   Any   preparation of

pharmaceutical   product   for   human   use   go   through   the   process   of   reviewing   and   assessing the dossier of pharmaceutical product which contains details information about administrative, quality, non-clinical and clinical data.

1. What are regulatory guidelines?

Regulatory Requirements means all applicable laws, rules, regulations, orders, requirements,

guidelines, interpretations, directives and requests (whether or not having the force of law) from and of, and plans, memoranda and agreements with, any Regulatory Authority.

1. What are the examples of regulated drugs?

Examples of  Schedule  II  narcotics  include:  hydromorphone  (Dilaudid®),  methadone  (Dolophine®),

meperidine    (Demerol®),    oxycodone    (OxyContin®,    Percocet®),    and    fentanyl    (Sublimaze®, Duragesic®). Other Schedule II narcotics include: morphine, opium, codeine, and hydrocodone.

1. What needs FDA approval?

Which Products Need FDA Approval?

• Human and animal drugs.
• Medical biologics.
• Medical devices.
• Food (including animal food)
• Tobacco products.
• Cosmetics.
• Electronic products that emit radiation.

1. How are drugs regulated?

Drug regulation:  The process  of  testing,  developing and  marketing of  medicines  has  to  regulated to

protect  the  interests  of  the  public.  Major regulatory bodies  include  the  Food  & Drug Administration

(FDA) in the US and the European Medicines Agency (EMA) in Europe.

1. What makes good regulatory affairs professional?

They must  be  detail  oriented  and  able  to  develop  realistic  action  plans  as  well  as  prioritizing work

activities – without these there are bound to be difficulties in keeping up with all the tasks

1. What is regulatory submission?

Regulatory submission is the process through which pharmaceutical companies submit the information

about  their  newly  developed  healthcare  product  to  a regulatory  agency  for  review.  They  can  also submit their documentation seeking additional knowledge about their device.

1. What are the 4 stages of drug development?

Drug Development Phases

• Phase 1: Discovery and Development.
• Phase 2: Preclinical Research.
• Phase 3: Clinical Research.
• Phase 4: FDA Review.
• Phase 5: FDA Post-Market Safety Monitoring.

1. What is CMC in regulatory affairs?

Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs (RA) is a specific area within RA

that has the ultimate responsibility for providing CMC regulatory leadership and strategy required to achieve regulatory approvals.

1. What is CTD format?

The Common Technical Document (CTD) is a set of specifications for an application dossier for the

registration  of  Medicines  and  designed  to  be  used  across  Europe,  Japan  and  the  United  States.  … Quality (pharmaceutical documentation)

1. How is dossier prepared in pharmaceutical products?

Abstract: Dossier is      a      collection      of      documents      on      the      particular      subjects.      Any

preparation of pharmaceutical  product for  human  use   go  through  the   process  of  reviewing  and assessing     the dossier of pharmaceutical     product which     contains     details     information     about administrative, quality, non-clinical and clinical data.

1. What does Ich stand for?

International Council for Harmonisation

The International  Council  for  Harmonisation of  Technical  Requirements  for  Pharmaceuticals  for Human  Use  (ICH)  is  an  initiative  that  brings  together  regulatory  authorities  and  pharmaceutical industry  to  discuss  scientific  and  technical  aspects  of  pharmaceutical  product  development  and registration.

1. What is a dossier file?

A dossier is a collection of papers or other sources, containing detailed information about a particular

person or subject.

1. How do you make a dossier?

To create a dossier

On  the  home  page  or  any  folder  page,  click  Create,  and  then  select  New  Dossier.  Your  dossier  is created and displayed, containing a single blank visualization. …

You can add data to the dossier in any of the following ways. … The selected data is added to your dossier as a dataset.

1. What is eCTD submission format?

eCTD.        The        Electronic        Common        Technical        Document        (eCTD)        is        the

standard format forsubmitting applications, amendments, supplements, and reports to FDA’s Center for

Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER).

1. What are FDA guidelines?

About FDA Guidances

Guidance documents  represent  the  Agency’s  current  thinking  on  a  particular  subject.  They  do  not create or confer any rights for or on any person and do not operate to bindFDA or the public.

1. Is the FDA a regulatory agency?

The  Food  and  Drug  Administration  (FDA)  is  a  government agency established  in  1906  with  the

passage of the Federal Food and Drugs Act.

1. What is the difference between compliance and regulatory?

In  general, compliance means  conforming  to  a  rule,  such  as  a  specification,  policy,  standard  or

law. Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations.

1. What are the 7 classifications of drugs?

7 Drug Categories

(1)  Central  Nervous  System  (CNS)  Depressants.  CNS  depressants  slow  down  the  operations  of  the brain and the body.

(2) CNS Stimulants. (3) Hallucinogens.

(4) Dissociative Anesthetics. (5) Narcotic Analgesics.

(6) Inhalants. (7) Cannabis.

1. Do natural products need FDA approval?

The     law does not require cosmetic products and ingredients,     except     for     color     additives,     to

be approved by FDA before they go on the market. … You are legally responsible for making sure your cosmetics are safe and properly labeled, in compliance with all the laws and regulations that apply to them.

1. What does CMC stand for in drug development?

CHEMISTRY, MANUFACTURING, AND CONTROL

Together,   these   processes   are   known   in   preclinical   and   clinical   development   as   chemistry, manufacturing,  and  control (CMC).  Many  aspects  of  drug  development  focus  on  satisfying  the regulatory requirements of drug licensing authorities.

1. What are ICH countries?

Regulatory Members

v  ANVISA, Brazil.

v  HSA, Singapore.

v  MFDS, Republic of Korea.

v  NMPA, China.

v  TFDA, Chinese Taipei.

1. What is the regulatory authority in India for pharmaceutical companies?

The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body for Indian

pharmaceuticals and     medical     devices,     and     serves     parallel     function     to     the     European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines.

1. Will fish survive ICH?

Fish that survive mild infections can develop immunity. There are currently no drugs or chemicals that

kill Ich while it resides in the fish skin or gills; they can only kill ICH when the parasite is in the water, and therefore all current therapies require a cyclical re-treatment program.

1. Who are the members of ICH?

ICH is now constituted by 16 Members and 28 Observers, after the ICH Assembly in 2018 approved

TFDA, Chinese Taipei as a new Regulatory Member, and MMDA, Moldova, NPRA, Malaysia, NRA,

Iran, SCDMTE, Armenia and TİTCK, Turkey as new Observers.

1. Is dossier a French word?

“Dossier,” the French word for such a compendium of spine-labeled folders, was picked up by English

speakers in the late 19th century. It comes from “dos,” the French word for “back,” which is in turn derived from “dorsum,” Latin for back.

1. What is a research dossier?

The  term dossier refers  to  the  application  materials  used  when  applying  for  academic  jobs.  …  The

career  development  center  is  available  to  review  all  aspects  of  your  dossier with  you  when  you  are applying for academic jobs. Below is an overview of teaching portfolios and teaching, research, and personal statements.

1. What is a dossier in Micro strategy?

About Dossiers. A dossier is an interactive display that you can use to quickly and easily explore your

business data. For example, you can: View visual representations of the data (called visualizations) in the dossier to make the data easier to interpret.

1. What is node extension in eCTD?

Node  Extension  Node  extensions are  a  way  of  providing  extended  organisational  information  in

the eCTD.  The node  extension should  be  visualised  as  an  extra  heading  in  the  CTD  structure  and should be displayed as such when the XML backbone is viewed.

1. What is FDA CFR?

The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published

in  the  Federal  Register  by  the  Executive  departments  and  agencies  of  the  Federal  Government.. Title 21 of the CFR is reserved for rules of the Food and Drug Administration.

1. What are CGMP guidelines?

The CGMP regulations  for  drugs  contain  minimum requirements for  the  methods,  facilities,  and

controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

1. Does FDA regulate alcohol?

The  Federal Alcohol Administration  Act  (―FAA‖) regulates the  interstate  and  foreign  commerce  of

wine, spirits, and malt beverages and bestows general authority to oversee these products to the TTB. Despite this, the labeling of some beers and some wines are regulated by the FDA.

1. What is a regulatory risk?

Regulatory  risk is  the risk that  a  change  in  laws  and regulations will  materially  impact  a  security,

business, sector, or market.

1. Why is regulatory compliance?

Protects your company. The regulations are there for a reason – they help protect your business, your

employees, and your customers. Failing to adhere to regulatory compliance requirements can open you up to risks beyond just fines.

1. What class of drug is crack?

Crack cocaine  is  a  Schedule  II  substance  under  the  Controlled  Substances  Act.  Schedule  II drugs,

which include PCP and metham- phetamine, have a high potential for abuse.

1. What percentage of drugs makes it through clinical trials?

New MIT Study Puts Clinical Research Success Rate at 14 %. Nearly 14percent of all drugs in clinical

trials eventually  win  approval  from  the  FDA  —  a  much  higher percentage than  previously  thought, according to a new study from the MIT Sloan School of Management

1. What are the 3 main GCP principles?

Three  basic  ethical  principles  of  equal  importance,  namely  respect  for  persons,  beneficence,  and

justice,  permeate  all  other  GCP  principles.  Research  involving  humans  should  be  scientifically justified and described in a clear, detailed protocol.

1. What are the three parts of a dossier?

Though  there  is  no  specifically  recognized  format,  the  teaching dossier typically  consists  of  two

basic components: a teaching narrative statement or philosophy, which is a short reflective narrative

(two to three pages), and an appendix, which consists of supporting documentation.

1. How do I create a dossier?

To create a dossier. On the home page or any folder page, click Create, and then select New Dossier.

Your dossier is  created  and  displayed,  containing  a  single  blank  visualization.  If  the  Getting Started page is displayed, click Get Started to open the dossier.

1. What is DMF in pharma?

Drug  Master  File  or DMF is  a  document  prepared  by  a pharmaceutical manufacturer  and  submitted

solely at its discretion to the appropriate regulatory authority in the intended drug market. There is no regulatory requirement to file a DMF.

1. What is NeeS submission?

This  Guidance  Document  is  intended  to  assist  pharmaceutical  companies  with  the  submission of

regulatory  information  in  electronic  format  to  the  National  Competent  Authorities  in  the  EEA (hereafter  referred  to  as  NCAs).  This  document  details  the  requirements  for the submission of  Non- eCTD electronic Submissions (NeeS).

1. Who controls the CFR?

The CFR is   divided   into   50   titles   that   represent   broad   areas   subject   to   federal   regulation.

The CFR annual edition is the codification of the general and permanent rules published by the Office of   the   Federal   Register   (part   of   the   National   Archives   and   Records   Administration)   and   the Government Publishing Office.

1. What does 510k mean?

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as

safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.

1. What is dossier in pharma?

―Registration Dossier‖ of the pharmaceutical product is a document that contains all the technical data

(administrative,  quality,  nonclinical  and  clinical)  of  a pharmaceutical  product  to  be  approved  /

registered / marketed in a country

CAREER PATH

The Drug Regulatory Affairs certification course organised with the help of Industry professionals from Regulatory Affairs.  Training is recognized across the globe. Because of the increased adoption of the  technology in various small and large pharmaceutical companies the participants are able to find the job opportunity easily. The leading companies hire Drug Regulatory Affairs to provide the most complete regulatory reporting which gains productivity in the pharmaceutical firms. The Drug Regulatory Affairs can pursue a wide range of career paths.

The following are the job titles:

• Consultant – Regulatory Affairs Executive
• Regulatory Executive
• RIMS 
• Risk management specialist