CambReg: Cambridge Regulatory Services: Your Partner for a full Regulatory Affairs Service

YOUR PARTNER
for a full Regulatory Affairs Service

CambReg: Your Partner for a full Regulatory Affairs Service

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Quality (Chemistry, Manufacture and Control - CMC)

You know that there will be CMC issues throughout the life of the product. Get ahead of the competition by learning from us where the pitfalls are and how to avoid them.

 

Our strong biotech knowledge and experience can help you decide on your route of synthesis before you embark on your clinical programme.

 

Consultancy Services:

 

• GMP compliance mock inspection
• Scientific Advice
• Gap analysis
• Recommendation of relevant contract houses

 

Dossier compilation Services:

 

• Certificate of Suitability
• Vaccine Antigen Master File Application
• Plasma Master File Application
• TSE Certification
• Module 3 and Quality Overall Summary preparation

Will you have enough material to start your preclinical studies?

 

Have you considered immunological properties to design your proof-of-concept studies?

 

Do your manufacturing standards comply with regulatory requirements?

 

Have you thought about due diligence to ensure contract organisations meet regulatory needs?

 

Biotech & Biologic: Quality

 

 

Take advantage of our strong in-house biotech team headed by Dr Mike James (ex-MHRA assessor with over 20 years' regulatory experience) and choose the most cost-effective route for your products.


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CambReg: Your Partner for a full Regulatory Affairs Service
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