Consulting Services

Professional Services

Your unique situation...

Are you a sterile manufacturer?
Are you an API manufacturer?
Do you need assistance with preparing your NDS/NDA, ANDA, NC or Drug Establishment License or Drug Master File?
Do you need assistance with preparation of CMC section of your submission?
Are you looking for a virtual QA to release your drug products and oversee your quality dept?
Do you require assistance validating your systems, facility, tests and GMP processes?
Are you having difficulty maintaining regulatory compliance?
Do you need to perform a due diligence exercise on a product that you are interested in in-licensing?
Have you had notice of an imminent authority inspection?
Your complaint system or CAPA program needs support to keep up?
Your change controls need to be managed more effectively?

If the answer to any of the above questions is yes, then you need Axsource Professional services.
Our services will allow you to:

Concentrate on the product development while we determine compliance systems
Streamline processes
License/register your products with relevant governmental agencies
Implement efficient change control
Navigate the regulatory hurdles more easily
Maintain control of product and validate processes, tests, equipment, utilities and computer systems
Provide expert inspectional support