ASPHALION´S SERVICES | Chemistry, manufacturing and controls

Complete CMC services, offering broad expertise for strengthening compliance and shortening deadlines

Complete CMC services, offering broad expertise for strengthening compliance and shortening deadlines
August 8, 2022
|

CMC is a fundamental requirement of all pharmaceutical applications to health regulatory agencies.​

At Asphalion, we have a team of experts with sound knowledge and experience in CMC in a wide range of pharmaceutical forms. We can either provide you with a full integrated support (from lab to market) or with a tailored support, at any stage of development, registration or during post-approval life cycle, managing different types of medicinal products and applications.

Whether you are looking for expert regulatory advice for life cycle maintenance services or new MAAs writing, or for support during development, Asphalion is the right partner to provide you with the best CMC approach.

Unburden yourself from maintenance work by outsourcing projects for entire portfolios.

Asphalion can optimize the life cycle management of your portfolio.

Have a look at the complete, more detailed solutions here:

ASPHALION CMC solutions

For further requests, you can send us an email at: [email protected]

Search News & Events

  • Filter by category

Share

Related news and events

NEWS | Important Update from the FDA!

This guidance recommends steps manufacturers and applicants of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in drug products. The guidance also describes conditions that may introduce nitrosamine impurities. The unexpected finding of nitrosamine impurities, which are probable or possible human carcinogens, in certain drug products has made clear the need for a risk assessment strategy for the potential presence of nitrosamines in any drug product.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting