We provide comprehensive support for achieving regulatory approvals from various global agencies. Our experts conduct pre-inspection GAP analyses, assist with QMS implementation and perform in-depth root cause audits to ensure seamless regulatory compliance.
Our regulatory affairs team specializes in the preparation and review of CTD and ACTD dossiers for global markets. We offer eCTD publishing and submission services, handle the preparation and review of DMF/CEP, Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs) and non-clinical & clinical overviews.
To support your European market entry, we provide a comprehensive suite of services, including Marketing Authorization Holder (M.A.H) representation, Qualified Person (Q.P.) designation, Qualified Pharmacovigilance Person (Q.P.P.V.) appointment, and batch releasing and testing/control site management.
Our experts facilitate smooth technology transfer by providing R&D development support and leveraging our extensive knowledge-base of EU-approved dossiers. We ensure the seamless integration of know-how and regulatory documentation to aid your market expansion efforts.
We offer comprehensive toxicology services, including risk assessments, safety threshold determination, and regulatory compliance support for pharmaceuticals, medical devices, and cosmetics.
Pharmaceuticals:
Occupational Safety and Cross Contamination Risk:
Medical Devices:
Cosmetics:
