Regulatory & Technical Support
Vitrology's regulatory and technical support team comprises of individuals each with a minimum of 10 years working in the biopharmaceutical industry and/or providing consulting services to industrial clients. This focus and the depth of functional expertise allows us to "hit the ground running" on complex projects, delivering value and support that other companies cannot match.

We specialize in areas involving the biological drug approval process, assay validation, equipment validation and quality assurance. We have substantial experience and knowledge of worldwide regulatory guidelines required for testing biological products. We also offer know how in GMP quality assurance, quality control, method validation, batch release and can provide our clients with consultancy in many areas to support dossier preparation. Expert reports can be customised to meet our client's requirements and we can provide assistance with drafting, executing or auditing IQs, OQs and PQs.

• Scientific & quality support
• Regulatory guidance support
• Complex biological testing strategies
• Data review
• Expert and technical report writing
• Assay and equipment validation
• Consultancy with regulatory authorities
• Assay development