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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
method of production before you embark on your clinical program.
Our
Services:
Consultancy Services
• GMP compliance mock inspection
• Scientific Advice
• Gap analysis
• Recommendation of relevant contract houses
Dossier compilation services
• TSE Certification
• Module 3 and Quality Overall Summary preparation
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Will you have enough material
to start your clinical studies?
Is your manufacturing in accordance with regulatory requirements?
Have you thought about due diligence to ensure contract
organisations meet regulatory needs?
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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