Global portfolio Due Diligence
Business Case: A big EU pharmaceutical company, interested in acquiring a whole set of worldwide brands from a company.
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:
– Solid, liquid and semisolid dosage forms
– Injectable (including freeze-dried), inhaled, topic and oral dosage 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.
We have broad expertise in 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.
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:
– Solid, liquid and semisolid dosage forms
– Injectable (including freeze-dried), inhaled, topic and oral dosage 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.
We have broad expertise in 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.
Chemistry, Manufacturing and Controls (CMC) Solutions
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Why Asphalion?
Our qualified team will be able to provide specific support for the different CMC requirements depending on the type of product, application and country, making sure to remain CMC compliant during the whole process.
We have up to 20 years CMC experience in Europe, US and Canada. In addition, we have also been working in other markets where Asphalion’s local partners can assist when field actions, use of local language or strategic local information is needed for the project.
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