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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.

Scheduled Batches

23 Sep
Weekends (5 Weekends)
Weekend Online |     07:00 AM-09:00 AM
18000
23 Sep
Weekends (5 Weekends)
Weekend Online |     08:00 AM-10:00 AM
18000
25 Sep
Weekdays (30 Days )
Weekdays Online |     06.30 AM - 07.30 AM
18000
25 Sep
Weekdays (30 Days)
Weekdays Online |     07.30 PM - 08.30 PM
18000

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
  • 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 
    Placement assistance
    Resume preparation
    Doubts Clarifications

Certifications

  • Certificate/Certification

    Covalent provides training certificate after completion of the course.

Videos

Drug Substance(API) Demo

Reviews

Akash

Drug Safety Associate

I am thankful to Covalent Trainings, for providing me proper guidance in opting this course. They explained very clearly, the potential of this course and opportunities in this.

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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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Srujana

API Analyst

The Quality of teaching is so good that always kept my interest on subject. The faculty treats in an amicable manner and clear every query at anytime. Providing special timing for working professionals was very helpful.

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JEENA SAMUEL

Drug Safety Associate

Thank you for your overall assistance during this Drug Substance course. Course was Excellent and the study Material was Precise which provided the Vast Knowledge and information about the RA for Drugs (API & Formulation) which will be of great help to me in present as well as in future.

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AMOL MOHAN SUL

Drug Safety Associate

The Distance Drug Substance(API) is a great overview of the Covalent diffdiffere and norms. Well structured and to the point course. Great courier and response service.

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Reena Roy

Drug Safety Associate

Covalent provides one of the best DRA programs in India. The classroom program gives a chance of interaction with industry faculty. Since it was a weekend program, I could easily pursue the same along with my current job.

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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.

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