Due-diligence for Pharmaceutical plants & CROs acquisition
We provide services for technically evaluating Pharmaceutical Plants CROs (Clinical Research & Contract Research Organisations) for acquisition. Due-diligence is conducted by experienced team members and provides consolidated report regarding facilities and technical competency of the unit.
API & Formulation manufacturers’ audit as vendor development
Vendor audit is done on contractual basis for clients, as a part of vendor development across the globe.
Guidance for implementing “Quality Management System” i.e. GMP, GLP & GCP
Team of experts provide guidance to Pharmaceutical Units & CROs for training and implementing Good Manufacturing Practices, Good Laboratory Practices & Good Clinical Practices.
We also help Pharmaceutical Units to upgrade the Facility & Quality Management System for approval by USFDA & EMA.
Help in resolving critical regulatory queries related to formulations
Regulatory queries are generally raised by regulatory agencies w.r.t. audit of facilities and documents submitted during filing ANDA & Dossiers and sometimes they are very critical and difficult to response, so we help in replying adequately to such critical queries in order to satisfy regulatory agency.
Guide in designing plants as per USFDA & EMA guidelines