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)