Chemistry, Manufacturing and Controls (CMC)

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

Chemistry, Manufacturing and Controls (CMC)

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:

  • Chemical entities
  • Biological
  • Herbal
  • ATMPs

And applications:

  • Innovative: chemicals and biologicals
  • Biosimilars
  • Hybrids
  • Well-established use
  • Generics

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:

  • Chemical entities
  • Biological
  • Herbal
  • ATMPs

And applications:

  • Innovative: chemicals and biologicals
  • Biosimilars
  • Hybrids
  • Well-established use
  • Generics

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.

Our Solutions

  • Strategic development and roadmaps – Integrated with non-clinical & clinical development
  • Gap analysis at every stage of drug development
  • Implementing and managing Quality by Design (QbD)
  • EU IMPD & US IND(A) – Writing, review and/or updates
  • Dossier writing, review and/or update – EU to US or US to EU
  • Due-diligence of in-licensed dossiers
  • Expert reports
  • Ad hoc regulatory strategy
  • Strategic development and roadmaps – Integrated with Non-clinical & Clinical development
  • Gap analysis at every stage of drug development
  • Implementing and managing Quality by Design (QbD)
  • EU IMPD & US IND(A) – Writing, review and/or updates
  • Dossier writing, review and/or update – EU to US or US to EU
  • Due-diligence of in-licensed dossiers
  • Expert Reports
  • Ad hoc regulatory strategy
  • Strategic development and roadmaps – Integrated with Non-clinical & Clinical development
  • Gap analysis at every stage of drug development
  • Implementing and managing Quality by Design (QbD)
  • EU IMPD & US IND(A) – Writing, review and/or updates
  • Dossier writing, review and/or update – EU to US or US to EU
  • Due-diligence of in-licensed dossiers
  • Expert reports
  • Ad hoc regulatory strategy

 

  • CTD Mod. 2 and 3 writing, review and/or updates for the EU and US, including:
    • EU ASMF and US/ROW DMF
    • Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP)
    • EU MAA (CP, DCP, MRP, NP)
    • US ANDA and NDA (505b1 and 505b2)
  • Dossier gap analysis (Mod. 2.3 and Mod. 3.2.S, 3.2.P and 3.2.R)
  • Due-diligence of in-licensing dossiers
  • Expert support on responses to deficiency letters
  • Expert reports

 

  • CMC regulatory strategy
  • CMC Regulatory compliance gap analysis
  • Updating dossier sections – Strategy, writing and review
  • Variations, renewals and notifications – Strategy, writing, review and/or update of dossier
  • Preparation and submission of grouped variations for Europe
  • Expert support on responses to deficiency letters
  • CMC Expert reports (including updates)
  • Dossier consolidation of legacy dossiers (Mod. 2.3 and 3) towards eCTD publishing
  • Ad hoc regulatory strategy
  • Complete portfolio maintenance for EU, USA, Canada and ROW

 

Schedule a free meeting!

Discuss your case with our experts and receive a valuable feedback

Downloads

Share

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.

Main benefits

  • Remain CMC compliant
  • Get specialized CMC expertise
  • Get support to meet tight deadlines
  • Anticipate and overcome potential CMC barriers
  • +65 CMC (Module 3)
Consol Bozzo - Asphalion
Consol Bozzo
Regulatory Affairs Director
“Our CMC services ranges from strategic advice to operational support. We can provide with high quality CMC services adapted to your needs. Flexibility and commitment to meet tight deadlines are one of our strengths as a team”
“After more than 20 years providing CMC services, we are in the position to offer an end-to-end and fully integrated set of CMC solutions to our clients. We have a broad range of expertise in handling different product types, including the most innovative, combined with a strong knowledge of the most relevant international regulatory frameworks and pathways”
André Mota - Asphalion
André Mota
Regulatory Affairs and Madrid Office Director

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