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We have extensive knowledge of the regulation of biotechnology
derived medicinal products and constantly monitor regulatory documentation
to provide clients with the most up to date testing and manufacturing
plans. The most appropriate use of current guidance is essential in ensuring
the most timely, cost effective and successful licensing of the therapeutic
product.
The specific testing requirements for different stages
of development, i.e., preclinical, clinical, and licensure, may vary worldwide.
BioReliance is experienced in working with clients to satisfy questions
raised by the regulatory agencies worldwide. Our services assist clients
in allowing their testing programs to meet current worldwide regulatory
expectations. This added value service can prevent regulatory holds that
delay marketing of pharmaceutical products. In some cases, we contact
the regulatory agencies with or on behalf of our clients. We also work
internally with Quality Assurance and Laboratory personnel to ensure that
BioReliance complies with the latest regulations.
BioReliance provides a range of Regulatory &
Technical Services activities including advice and consultancy in support of dossier preparation and submissions. Specific reports can be
prepared depending on our client’s unique requirements. These can
be provided as stand-alone documents or as part of the entire submission.
Therefore, BioReliance’s Regulatory & Technical
Services group provides:
- Regulatory information services
- Ensuring up to date advice
- Advice on regulatory strategies
- Data review and evaluations
- Expert report writing
- Preparation of documentation
- Response to authorities
- Technical support
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