Pharma-Bio Serv offers solutions to the Pharmaceutical, Biotechnology, Medical Devices, Food, and Chemical Industries by providing a comprehensive range of services to our clients, to ensure Regulatory Compliance.
We are leaders in Quality Risk Management and have real life project experience in the successful implementation of QRM Strategies.
Our support for customers is through-out the product lifecycle:
- R&D Studies
- NDA Documentation and Filings
- PAI Readiness
- Audit & Inspection Preparation, Management and Response
- Post Approval
- Quality Systems
- Technology Transfer
- Manufacturing Controls & Process Support
We are your partner in cGMP compliance through all stages of manufacturing, supplemented with training. Once product has been transferred to manufacturing, we support the manufacturing processes to maintain state of control by implementing the latest standards such as Validation Guidance, ICH Guidelines, Process Excellence and Risk Management tools.
Our Services are in accordance with the latest FDA, European Medicines Agency and other international agency regulations and guidelines. All our services are founded on a Philosophy of Excellence through our personalized hands-on experience and our trained resources.
All work performed is properly recorded through high quality documentation. We strongly enforce, and give due attention to, documentation quality and accuracy in line with cGMP requirements.