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

Asphalion CMC End to End support during product life-cycle

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

CMC writing and consulting - Development strategy & roadmaps

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

CMC technical writing and consulting - Support during Registration

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

CMC technical writing and consulting - Support for Maintenance

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

CMC technical writing and consulting: EU API: ASMF and CEP, US (Regional) DMF

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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Discuss your case with our experts and receive a valuable feedback

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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

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”

“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.”