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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. Consider
your route of synthesis carefully before you embark on your
non-clinical and clinical programme, ensuring that your production
methods are commercially scalable.
Consultancy
Services:
• Gap analysis
• GMP compliance, mock inspection
• Recommendation of relevant contract houses
Dossier compilation services:
• Certificate of Suitability
• DMF Application
• TSE Certification
• Module 3 and Quality Overall Summary preparation |
Will you have enough
material to start your preclinical studies?
Are you embarking on
key studies with material with an unrepresentative impurity
profile?
Will you have enough stability data to support your
Clinical Trial Application?
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Take advantage
of our strong in-house CMC team headed by Dr Mike James (ex-MHRA
assessor with more than 20 years' regulatory experience) and
choose the most cost-effective route for your products. |
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