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Drug Substance (API)

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. 
  • Lifetime Access

    You can get lifetime availability of class recordings and presentations can be shared with you, you can download and Stored in your system.
  • 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
  • Drug Substance(API)

    Topic 1: Introduction to RA

    Topic 2: CMC of API

    Topic 3: CTD

    Introduction about CTD/eCTD, origin of CTD and brief description about Module 3

    Topic 4: Drug substance submissionin US

    Topic 5: Drug substance submissionin Europe

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 
    Lab facilities
    Placement assistance
    Resume preparation
    Software installation
    Doughts Clarification & Job Support.

Certifications

  • Certificate/Certification

    Covalent provides training certificate after completion of the course.

Videos

Drug Substance(API) Demo

Reviews

Ramya Krishnan K

QA Analyst

Hi This is Ramya from Chennai. I am working for a pharma company in QA department. for career development I learnt RA Course at Covalent. and after it help me to upgrade my self in to Regulatory department from QA. Thanks Covalent.

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