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
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?
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.