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Regulatory Affairs (Middle 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

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  • Regulatory Affairs (Middle 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 (Middle Level) Demo

Reviews

Sai Teja

Sr. Executive

I liked the institute atmosphere and the way they approached was very impressive The coaching is good and they teach it in a very simple way to understand.

 

 

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Hima Bindhu K

Fresher

I would like to thank Covalent for the training & knowledge offrered to me during my study of regulatory affairs at the institute overall great learning exeperience. The teaching pattern is very interactive & innovative which includes case studies, group disscussion,presentation, etc.

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VINAY KUMAR B

Regulatory Affairs Excutive

I have been a part of Covalent for Regulatory Affairs(Middle Level) Training. My experience with Covalent was eye opening. Both my trainers & counseling are exceptionally knowledgeable people. They always make sure each and every student gets their personal attention.

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Chandrasekhar

Sr. Executive

Covalent is one of the best platform for Pharma Trainings. This is the place where I have gained knowledge in different sectors in QC and RA in Pharmaceutical and Manufacturing Industries. With the help of training and guidance got an opportunity with Mylon Laboratories.

readmore...

Appa Rao

DRA Department

Hi This is Appa Rao. I am Selected for DRA Department in Honour Labs . for career development I learnt RA Middle level Course at Covalent.Thank you very much to covalent trainings staff. 

readmore...

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