Pharmaceutical Regulatory Services

A well designed and stage appropriate quality management system (QMS) is essential for development and commercialisation of pharmaceutical products. We understand the complexities of managing quality and regulatory compliance in the pharmaceutical industry.

Our Quality and Regulatory services include:

• Quality issue management – investigations, out-of-specification (OOS), deviations, corrective and preventive action (CAPA).
• Assistance with vendor selection, qualification, and auditing.
• Review and management of quality agreements.
• Quality and regulatory review of development records, technology transfer records, master/executed batch records, specifications, test methods, validation and stability protocols and reports for adequacy and accuracy.
• Prior approval inspection readiness assessment and training.
• Subject Matter Expertise (SME) for risk assessment of extractables and leachables and nitrosamines as per ICH M7 and ICHQ3D.
• CMC data compilation and expert review for drug master file (DMF), Dossiers, investigational new drug (IND), and new drug application (NDA).
• Regulatory strategy for registrations and life cycle management.
• Review and assessment of regulatory submission documents and data for gap analysis and compliance.
• Support for addressing regulatory deficiencies on DMF, Dossiers, abbreviated new drug application (ANDA), IND, and NDA filings.