Regulatory Affairs

Comprehensive training on current regulations and their practical application

This project will provide the fundamental skills you need to do your job in Drug Regulatory Affairs. Topics include but are not limited to:

  • US regulatory affairs: the IND and NDA and post-marketing
  • European regulatory requirements
  • Preparing for FDA meetings
  • Post-approval regulatory requirements
  • Regulatory requirements for product labeling & advertising
  • Electronic submissions
  • Quality assurance
  • Biosimilars
  • Biologic products
  • Drug development

The project within Regulatory Affairs include:

Global & Regional Drug Project Delivery: encompassing Global Regulatory Leaders; Regional Regulatory Affairs Directors; Regulatory Affairs Managers; Global Labelling; Regulatory CMC; and our Submissions Management Group

Regulatory Policy & Intelligence

Global Regulatory Operations: including Business Learning & Process Development; Quality Assurance & Compliance; Regulatory Informatics; and Global Electronic Library Governance

Following topics  will be covered in the project:

  • Basics of Regulatory Affairs
  • International Guidelines Impacting Regulatory Affairs
  • Domestic Licensing and Approvals
  • Overview of Health Authorities of the world
  • Introduction to Regulatory Documents
  • Clinical Trial Applications
  • Dossier Publishing and Submissions
  • Facing Audits as Regulatory Professional 

 

 

Connect with us

Contact

GRATISOL LABS – HYDERABAD
KVR Enclave, 2nd Floor, 207, Gurudwara Lane,
Beside Satyam Theater, Above ICICI Bank,
Ameerpet, Hyderabad– 500016,
Cell: +91 9705790302 / +91 8885198390
E-mail: training@gratisol.com