Regulatory Affairs (Middle Level)

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

• Regulatory Affairs (Middle Level)

  Topic 1: Introduction to RA
  Topic 2: ICH guidelines
  Topic 3: CTD – eCTD
  Topic 4: Drug Development Process.
  Topic 5: Generic Drugs
  Topic 6: Drug approval procedure in US
  Topic 7: Drug approval procedure in Europe
  Topic 8: Discussion on deficiencies received from authorities and how to address the quires effectively.
  Topic 9: Resume preparation and interview questions.

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.