ASPHALION CMC SOLUTIONS

At Asphalion, we have a sound knowledge and experience in a wide range of pharmaceutical forms and types of products.

July 1, 2021

♢ At Asphalion, we have a sound knowledge and experience in a wide range of pharmaceutical forms and types of products.

♢ We can either provide you with a full integrated support (from lab to market) or a tailored support as per your specific needs, at any stage of development or during post-approval lifecycle of Human Medicinal Products.

♢ Our EU/US CMC experts that can actively collaborate with you on:

PHARMACEUTICAL DEVELOPMENT
REGISTRATIONS / APPLICATIONS
MAINTENANCE / LIFECYCLE MANAGEMENT

♢ Have a look at the CMC solutions and related services we can help you with at the attached brochure.

♢ If you have any questions, do not hesitate to contact us at: info@asphalion.com

Search News & Events

FORUM INSTITUT COURSE | CMC Management in Regulatory Affairs

September 19, 2023

ASPHALION expert André Mota, together with other two excellent lecturers will share their in-depth knowledge with you on CMC Management in Regulatory Affairs. The online

Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs)

September 5, 2023

Recently, the U.S. Food and Drug Administration (FDA) made a notable advancement in protecting public health by releasing a fresh set of guidelines, “Recommended Acceptable

ICH M7 Guideline | Assessment and Control of DNA reactive impurities in pharmaceuticals

August 30, 2023

The European Medicines Agency Committee for Medicinal Products for Human Use published recently a new Question and Answer document, following the publication of Revision 2

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ASPHALION CMC SOLUTIONS

At Asphalion, we have a sound knowledge and experience in a wide range of pharmaceutical forms and types of products.

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Related news and events

FORUM INSTITUT COURSE | CMC Management in Regulatory Affairs

Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs)

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ASPHALION CMC SOLUTIONS

At Asphalion, we have a sound knowledge and experience in a wide range of pharmaceutical forms and types of products.

Search

Filter by category

Related news and events

FORUM INSTITUT COURSE | CMC Management in Regulatory Affairs

Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs)

ICH M7 Guideline | Assessment and Control of DNA reactive impurities in pharmaceuticals

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