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Dossier/ANDA Compilation Program

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

29 Sep
Weekdays (45 Days)
Weekdays Online |     08.00 AM - 09.00 AM
15950
30 Sep
Weekends (45 Days)
Weekend Online |     08.00 AM - 10.00 AM
15950

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
  • Dossier/ANDA compilation program

    Topic 1: Introduction to RA

    Topic 2: CTD
     
    about CTD/eCTD, origin of CTD and brief description about each section in the modules along with Hands on experience in CTD dossier compilation.

    Module 1 - Administrative and Prescribing Information
    Module 2 – Common Technical Document Summaries

    Module 3 –Quality Part
    Module 4 - Nonclinical Study Reports
    Module 5 -Clinical Study Reports


    Topic 3: Hands on experience in dossier compilation activity.

    Interview Etiquettes:

Projects

  • Dossier/ANDA compilation project

    Dossier/ANDA compilation project--Real Time Project

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

Dossier compilation Demo

Reviews

Shivathmika

Fresher

I would like to thank Covalent for their support throughout the training. After completion of my B.Pharm, I have joined Covalent for Dossier/ANDA Compilation Program. After a month of course completion I got placed in TCS. Thanks to Covalent for high quality training and support.

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Janardhan Reddy P

Production Chemist

One of the best training institute in India,

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Shiva Reddy

Fresher

Covalent Trainings is one of the best Institute/company that i have seen in Hyderabad for ANDA Training. Faculty is well experienced and they come up with really good techniques, so that everyone can easily understand the concepts.

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Sahana Sharma

Fresher

Classroom program is very beneficial for working professionals like me. I attended lectures on weekends which were conducted by Industry people having vast amount of experience.

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