Chemistry, Manufacturing and Controls (CMC)

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

Chemistry, Manufacturing and Controls (CMC)

Chemistry, Manufacturing, and Controls (CMC) are pivotal elements in all pharmaceutical applications submitted to health regulatory agencies.

At Asphalion, we pride ourselves for having deep knowledge and extensive experience in CMC across wide range of:

Drug substance types:

  • small/large molecules
  • organic and inorganic chemicals
  • biotech, herbals

Drug product types:

  • solid, semi-solid and liquid dosage forms
  • sterile and non-sterile
  • standalone products and combination products

Complex products:

  • radiopharmaceuticals, nanoparticles
  • biologics: peptides, antibodies, viral gene therapies
  • ATMPs: cell & gene therapy, engineered tissues

Legal basis:

  • innovative
  • generics/biosimilars
  • hybrids
  • well-established

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 tailor-based services.

Asphalion can optimize the life cycle management of your entire portfolio easing the burden on your team.

Chemistry, Manufacturing and Controls (CMC) Solutions

Early CMC development

  • Regulatory strategy
  • Feasibility assessments
  • Risk management
  • QbD principles
  • Full support on analytical methods

Clinical phase CMC development

  • Good Manufacturing Practice (GMP) compliance
  • IMPDs, pre-INDs/INDs CMC preparation
  • Comparability exercises
  • Scaling up to commercial scale and technology transfer
  • Substantial and non-substantial amendments for INDs and IMPDs

Marketing Authorization Application

  • Writing of CMC sections of regulatory submissions (MAAs, BLAs, Module 2.3, Module 3)
  • Analytical comparability exercises
  • Response to Regulatory Authorities’ questions on CMC issues

Post-approval activities

  • CMC change control
  • Strategy, writing and submission of post-approval changes
  • Analytical comparability exercises

How can we help?

Our skilled team as extensive experience in CMC projects, including:

  • Implementing and managing Quality by Design
  • EU IMPD & US IND(A) – writing, review and/or updates
  • Dossier writing, review and/or update – EU to US or US to EU
  • Gap analysis at every stage of development

Regulatory meetings with EU and US agencies

Strategy validation with main Competent Authorities, including:

  • Regulatory strategy definition of development
  • Preparation of regulatory documents: List of Questions and Company position
  • Support for meeting preparation
  • Support during meeting
  • 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)
  • Dossier gap analysis
  • Regulatory compliance gap analysis
  • Expert support on responses to Deficiency Letters
  • Due-diligence of in-licensing dossiers
  • Dossier refurbishment according to new/different requirements for RoW registration purposes
  • Variations – strategy, writing, review and/or update of dossier
  • Renewals – strategy, writing, review and/or update of dossier
  • Extensions – strategy, writing, review and/or update of dossier
  • Repeated-use
  • Change control assessment
  • Dossier consolidation of legacy dossiers towards eCTD publishing

REGULATORY SUPPORT AND STRATEGY WRITING           

  • ASMF, CEP, US DMF and regional DMF Dossier Due diligence and Gap analysis
  • Module writing for Active pharmaceutical ingredient (API)
  • Response to questions
  • PUBLISHING
  • Publishing in eCTD
  • SUBMISSION
  • Life-cycle management
  • Revisions preparations and renewals

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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.

Main benefits

  • Remain CMC compliant
  • Get specialized CMC expertise
  • Get support to meet tight deadlines
  • Anticipate and overcome potential CMC barriers
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
Consultancy Operations Director | Madrid Office
Izabela Bedziak
Izabela Bedziak
Scientific & Regulatory Affairs Associate Director
“Navigating the expansion of your product’s market and consumer reach can be complex.
We are committed to offering the guidance and support needed to make this journey as smooth and successful as possible.”

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