Regulatory Affairs

We are up-to-date on all developments of pharmaceutical and medical technology legislations across the world. We help you make the right choice. We provide full or shared regulatory responsibility in relation to:

Regulatory Affairs:

• Regulatory writing for Dossier’s and Gap Assessment with customization.
• End to End support for eCTD, Post Approval Life Cycle Management.
• Responding to the dossier deficiencies and support till product approval.

Regulatory Compliance:

• Support for GMP/Facility audit.
• Post Approval product launch and regulatory compliance support.
• Life cycle management like Annual reports, Variations and product renewals.