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Regulatory Affairs Services

Aurigene Pharmaceutical Services’ Regulatory Affairs services team helps our clients to navigate the global regulatory landscape. Our team has a track record of handling filings with the US FDA, EMA, MHRA, KFDA, PMDA, EDQM and CFDA.

Our Regulatory Affairs Services team will work with you for pre and post-marketing requirements, including:

 

Dossier Compilation and Regulatory Submission

  • Writing and reviewing of Module 2 and 3 CTD sections for all regulatory submissions (e.g. pre-clinical phase, INDs, IMPD-CTAs phase I, II & III, MAAs, NDAs, DMFs, ASMFs, CEPs, variations, amendments/supplements and briefing documents for regulatory agencies’ submissions and meetings)
  • Specific support of other modules (Module 1, 4 & 5 of CTD) as per requirement
 

Gap Analysis and Risk Mitigation

  • Review/due diligence of drug substance/drug product dossiers, CMC content and Drug master files (DMFs)
  • Dossiers and DMFs amendment for customized submission with appropriate risk mitigation strategy
 

Queries/Deficiency Management

  • Handling of regulatory queries and timely submission of responses to regulatory agencies
  • Ensuring that development objectives are met and approvals are received on time
 

Regulatory Strategy and Development Support

  • Support during pre-filing discussions, scientific advice and pre-submission meetings with health authorities, e.g. pre-IND meetings
  • In-depth reviews of protocols (e.g. stability protocol, various development protocol), reports (e.g. Process development/optimization report, process validation report) and other documents (e.g. analytical documents, batch records, stability documents)
 

Regulatory Compliance and Life Cycle Maintenance

  • Support for regulatory compliance of products under development and review, including notifications and amendments
  • Regulatory impact assessments for unapproved, approved or commercial products through review of change control and appropriate variation or supplement filing
  • Support for renewal and annual reports filing
 

Regulatory Intelligence

  • Knowledge of the complete product development and lifecycle for pharmaceutical products, including APIs
  • Experts in US FDA requirements, European regulations, and globally applicable regulatory standards (ICH & WHO guidelines)
 

Regulatory Intelligence

  • Assessment of GMP issues and QP declaration for GMP
  • Participation in inspections and audits (GMP audits) at sites involved in the manufacturing and distribution of products
  • Document review and compliance check for product quality
  • QP release for IMPs and commercial products
 

Additional Services

  • Support to manufacturing units and strategic business partners for audit preparation
  • Guidance to labeling group for finalization of product information (e.g. pack insert, medication guide, SmPC, PIL, user testing and mock ups)