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Regulatory Affairs (Expert Level)

Regulatory affairs is a comparatively new profession which 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.

Why this course ?

Regulatory affairs is a comparatively new profession which 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.

Course Features

  • Instructor Live Sessions

    There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
  • Real Time Studies

    Live project based on any of the selected use cases on the above selected Domain.
  • Assignments

    Each class will be followed by practical assignments which can be completed before the next class. 
  • 24/7 Support

    We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.
  • Certification

    Towards the end of the course, you will be working on a project. Covalent certifies you as an course Expert based on the project.

Course Curriculum

Download
  • Regulatory Affairs (Expert Level)

     Course Topics

    • ICH Guidelines
    • SUPAC Guidelines
    • Regulatory Guidelines
    • Regulatory Submission

                  USFDA

                  EMEA

                  Indian (Domestic) 

    • Preparing response to Deficiencies
    • DMF’s

     

    Part I

    1. ICH GUIDELINES 
    1. SUPAC GUIDELINES 
    1. INTRODUCTION AND GENERAL OVERVIEW OF PHARMACEUTICAL INDUSTRY 
    • Functions and types of DOSAGE Forms
    • Definitions and various departments in an industry
    • RA as a Profession and its Importance
    • Code of ethics of regulatory profession
    • Functions of RA
    • Importance of QA and its Link with RA.
    • Origin of drug development process and filings

     

    Part II

    1. REGULATORY SUBMISSION 

              USFDA

    • Drug Firm Establishment Registration with US-FDA (FEI No.)
    • NDC No. and DUNS
    • Generic Drug Submission
    • Preparation, Review and Submission of Application to USFDA.
    • Technical Support in CMC-Writing
    • Technical writing of Specifications, Test Procedures, Method/ Process Validation Protocols/Reports, BMR/BPR
    • Manufacturing Formula and Process
    • Preparation of Labels and Pack Insert
    • Consulting and preparation of all modules (M-1, M-2, M-3, M-5) for registration purpose in any country as per latest country specific guidelines.
      • Review, evaluation and Gap Analysis for compiled dossiers
      • Respond to deficiencies raised by regulatory authorities

             

               EMEA

    • EU Commission
    • Procedures
    • Guidelines and Eudralex
    • Gap Analysis
    • Dossier writing for MAA
    • Preparation of SmPC, PIL
    • Responses to deficiencies.
    • Life Cycle management

     

    Part III

    Indian Regulatory Filing and Emerging markets

    • Dossier preparation
    • ICH CTD, ASEAN CTD and Country specific formats.
    • Prepare documents for company registrations in various countries.
    • Review, evaluation and gap analysis for compiled dossiers.
    • Renewal of registrations.
    • Prepare documents to file variations in case of Approved/Registered products.
    • Arrange GMP inspections
    • Preparation of SMF
    • Quality overall summary
    • Technical Support in CMC-Writing
    • Technical writing of Specifications, Test Procedures, Method/ Process Validation Protocols/Reports, BMR/BPR
    • Manufacturing Formula and Process
    • Preparation of Labels and Pack Insert
    • Review, evaluation and gap analysis for compile dossiers.
    • Respond to deficiencies raised by regulatory authorities.

     

    Part IV

    1. DMF
    • Introduction of DMF’s
    • DMF process
    • DMF Formats
    • DMF contents
    • Difference between US and Europe DMF’s

     

    Highlights

    • Critical Review of Dossier and Preparation of GAP Analysis Report
    • Re-formatting old Dossier/DMF, NTA to CTD/eCTD format
    • Technical Support in CMC-Writing, SOP Writing, Protocol Writing, Expert report (QOS) preparation
    • Technical writing of Specifications, Test Procedures, Method/ Process Validation Protocols/Reports, BMR/BPR, Manufacturing Formula and Process
    • Handling deficiencies
    • Life Cycle Management

     

Projects

  • Real time projects on Regulatory Affairs

    Covalent Provides Realtime projects working on Documentation process, Dossier preparation, CTD, e-CTD, ICH, GCP, MHRA Guidelance.

    Working on National and International Regulations.

FAQ's

  • Can I attend a demo session before enrollment?

    Yes

  • What if I miss a class ?

    If you miss a class we can provide recording video for particular session or we can arrange you the back up session.

  • Will I get placement Assistance ?

    Yes

  • Do I receive a certificate for training ?

    Yes

  • What support is available after the training?

    Doubts clarification up to getting a job

    Resume preparation

    Malk interviews

    Placement Assistance

  • What Features do you provide?

    Class Room & Online Live sessions
    Real-time projects
    Working faculties 
    Placement assistance
    Resume preparation
    Doubts Clarifications

Certifications

  • Certificate/Certification

    Covalent provides training certificate after completion of the course.

Videos

Regulatory Affairs (Expert Level) Demo

Reviews

Shiva Kumar C

Medical Coder

I would like to thank Covalent Technologies for best training and Placements. I have 4 Years of experience in to Medical Coding, after that I quit my job because I am not comfortable with the job, Then I heard about Covalent and joined Regulatory Affairs for 3 Months. Then with the help of management got an opportunity with Aurobindo Pharma.

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Sailaja

DRA Department

Covalent Trainings offered complete Syllabus at the Expert level. Faculties are 12+ Years of experienced professionals. Already i am in DRA Department but i need more knowledge. so joined in Covalent. what I expect, covalent teaches more than my expectation levels.

readmore...

Prathibha P

Drug Safety Associate

It was very helpful for me coming from the non pharma background. All the lectures which are given by the experienced teachers and guest lecturers are in that particular field and i m currently experiencing that it's really helping a lot.

readmore...

A.HANNA

Fresher

I did not get any placement from my college from last 3 years, I was struggling to get a good job in pharmacy field. After some days I came to know from my friends about Covalent Pharmacy Certification.

readmore...

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