Regulatory Affairs

Regulatory Affairs

Regulatory Affairs

Commercial activity in regulated/semi-regulated countries shall start from filing the DMF (for APIs/pellets) and ANDA/dossier (for Formulations) with respective approvals from regulatory authorities i.e., MARKETING AUTHORIZATIONS. 

Regulations for dossier filing/marketing authorizations will differ from country to country. The same is the case with both drug substance (API) and drug product (Formulations). 

Evaluating the data of medicinal product wrt Quality, Safety and Efficacy is utmost important to obtain dossier approvals.

RegPat Solutions is geared-up in providing all Regulatory services to the client which comprises of 

♦   Advise on a full range of regulatory compliance and scientific Services.

 

♦   Provide consulting services including regulatory strategy and quality support.

 

♦   Regulatory Submission Road maps

 

♦   Dossier compilation for Global regulatory submissions

 

♦   Advise on a full range of regulatory compliance and scientific Services.
  • CMC dossier writing, eCTD/CTD, country specific dossiers to the client for submitting to global regulatory agencies to get marketing authorizations.

 

♦   Regulatory Compliance and Gap Analysis

 

♦   Post Approval Changes/variation Submissions

 

♦   Product Lifecycle Management
  • Support life cycle management regulatory approvals including submission of amendments, supplements, annual reports, and other regulatory documents.

 

♦   Global Labeling/artwork services
  • Packaging Artwork Process Consulting.
  • Artwork Lifecycle Coordination.
  • Artwork Proofreading / Quality Check.
  • Artwork RA Labeling.
  • Content to Carton.