Pharma-Bio Serv offers solutions to the Pharmaceutical, Biotechnology, Medical Devices, Food, and Chemical Industries by providing comprehensive range of services to ensure regulatory compliance to our clients. We are leaders of Quality Risk Management and have real life experience by successfully implementing Quality Risk Management Strategies and Projects. We currently support Stages 3 and 4 of the Clinical Phases, from R&D studies, NDA documentation and Filings, PAI, Site Registration, Technology Transfer of New Products and Post Approvals. We support all stages of manufacturing processes, supplemented with training and certification of our client's personnel. Once product has been transferred to manufacturing, we also support the manufacturing processes to maintain its state of control by implementing the latest practices, such as Process Excellence and Risk Management tools.
Our Services are in accordance with the latest FDA/EMEA and other international agencies regulations and guidelines. All our services are founded on a Philosophy of excellence through personalized hands on experienced and trained resources.
All work performed is properly documented through high quality documentation. We strongly enforce and pay attention to documentation quality and accuracy being an important cGMP requirement.
We provide holistic regulatory compliance services to our clients, including areas such as Environmental, Safety and Occupational Health areas.