Pharma-Bio Serv - Services

By: Pharma-bio Serv  05/12/2011
Keywords: Risk Management, Regulatory Compliance, technology transfer

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.

Keywords: Quality Risk Management, Regulatory Compliance, Risk Management, Risk Management Strategies, technology transfer,

Other products and services from Pharma-bio Serv

05/12/2011

Pharma-Bio Serv - Chemical and Microbiology Laboratory Support

Chemical Qualitative/Quantitative Analysis of Raw Materials, Finished Goods and Stability. SOPs development and training in Compliance with USP, EP, JP and FDA Guidelines.


05/12/2011

Pharma-Bio Serv - Commissioning Qualification and Validation

Manufacturing Process Validation: Bio, Vaccines, Pharma, Med Devices, Consumer Products. Interpretation and Application of Quality Risk Management Guidelines. Manufacturing and Packaging Equipment Qualification. Active Drug Solubilities and Sampling. New Approaches to Cleaning Validation.


05/12/2011

Pharma-Bio Serv - Computer Systems Validation

Company Policies must be in place to establish the systems methodology to computer validation, combined with a systems based and risk management approach. Computer Systems and Software Validation is a requirement of the FDA 21 CFR and EMEA. 21 CFR Part 11 Corrective Action Plans. Development Test Plans & Report. Source Code Review and Testing.