Pharmaceutical Development & CMC
Our CMC team plans, monitors, and documents drug substance and drug product pharmaceutical development under one coordinated program, aligned with your overall development plan and supply strategy.
Examples of How We Support
These are just examples to illustrate the kind of work we do day to day. The fastest way is usually a short call to understand your situation and discuss how we can help.
CMC capacity gap
Module 3, IMPD, and IND writing runs in parallel to analytical and CDMO work, and resources are limited.
Multi-region submissions
Dossier formats and expectations differ, you need one plan that supports EU, US, Japan, and other regions.
Formulation or stability risk
Early data points to weaknesses and the CMC plan needs adjustment before it becomes a dossier issue.
Tech transfer or supplier change
Vendor qualification, quality agreements, and comparability need to be managed without losing time.
Drug device combination products
Device-related elements, for example extractables and leachables and usability inputs, need to fit into one consistent submission story.
Device drug combination products
Input on the requirements for the auxiliary medicinal part of the device including preparation of the documentation, Module 2.3 and 3, and qualification of related vendors.
Understanding Pharmaceutical Development & CMC
Getting from an early candidate to a regulatory-ready dossier takes more than a great API. Our Chemistry, Manufacturing and Controls (CMC) team plans, monitors, and documents drug substances and drug product pharmaceutical development under one coordinated program, aligned with your overall development plan and supply strategy. We connect process development, Quality by Design (QbD), and global regulatory requirements so the package is consistent, submission-ready, ready for scale-up, and launch.
We do not just advise. We write the CMC content, manage the interfaces with CDMOs and labs, and support authority questions as the dossier moves forward.
Pharmaceutical development can mean the full journey from a candidate compound through nonclinical and clinical development to approval. We do cover that end-to-end across our preclinical, clinical, regulatory, and safety teams. On this page, we use "pharmaceutical development" in the CMC sense, as it appears in the quality dossier. This is the CMC team's scope.
We support both drug substance and drug product work, including formulation, process development, scale-up and tech transfer, stability studies, packaging, and global CTD Module 3 authoring. We write and compile the CMC content, manage the interfaces with CDMOs and labs, and support authority questions as the submission moves forward.
The CMC team does not operate in isolation. It works closely with Preclinical Development, Clinical Development, Regulatory Strategy & Operations, and Quality & Compliance to ensure data generation and documentation align with the overarching development plan and regulatory strategy.
What We Do
Our Workstreams
We structure our CMC support into clear workstreams with defined outputs and interfaces.
Program Management and Strategy
TPP/CQA definition; vendor selection and qualification; multi-region CMC roadmaps; quality agreement negotiation; risk management and gap analysis.
Drug Substance Development
Process development and scale-up for synthetic, semi-synthetic, herbal and biotech APIs. Starting material and control strategy justification in accordance with ICH Q11. Stability studies. ASMF/DMF preparation and acting as EU regulatory representative.
Drug Product Development
Formulation design across dosage forms; process development and tech transfer; primary and secondary packaging selection and qualification; elemental impurity (ICH Q3D) and nitrosamine risk assessments (future ICH Q3E) with toxicological evaluations; IMP manufacturing support.
Analytical and Risk Assessment
Method development and validation; impurity profiling; extractables/leachables studies; design of global stability programs accounting for supply chain and environmental factors; QbD and design space documentation.
Regulatory Documentation and Submissions
Authoring and maintenance of IMPD/IND Quality sections (Module 3), CTD Modules 2.3/3; CEP applications and lifecycle support; ASMFs/DMFs for EU, US, Japan, and other ICH regions; variation and renewal dossiers.
Lifecycle Management and Transfers
Post-approval variations and renewals; tech transfers between sites; Site Master Files (SMFs), SOPs, ongoing GMP/GDP documentation and audit readiness.
Where This Fits in the Development Journey
CMC work looks different depending on the development phase. The goal stays the same: keep data generation and documentation aligned across your internal teams and external partners, so the CMC story remains consistent and submission-ready.
Discovery & Concept
Define TPP/QTPP and initial CQAs. Set a phase-appropriate CMC roadmap, key risks, and an initial control strategy concept.
Preclinical
Formulation and process prototyping. Analytical feasibility and early method development. Starting material and supplier strategy. Early impurity and nitrosamine risk assessment. Seed QMS and vendor qualification needs to support the next phase.
Design & Development
Optimise processes and unit operations. Define specifications and control strategy. Develop methods and validation plan. Build the tech transfer package and scale-up strategy. QbD documentation where appropriate.
Clinical
Plan and manufacture IMP, including EU GMP Annex 13 considerations. Manage QA/QP release inputs, batch record review, deviations, and stability. Coordinate clinical packaging and labelling requirements. Integrate device components where applicable.
Regulatory Submission & Approval
Author and compile CMC regulatory content (IMPD/IND quality sections, CTD Modules 2.3 and 3). Prepare ASMF/DMF and CEP dossiers where relevant. Support authority questions and RFIs. Drive inspection readiness on the CMC side (documentation, site readiness inputs).
Launch & Market Access
Prepare commercial manufacturing readiness (process validation strategy and execution support as applicable). Finalise packaging components and supply chain qualification. Set up ongoing verification and release processes.
Post-Market & Lifecycle Management
Manage CMC lifecycle activities: change control, variations, renewals, supplier changes, tech transfers, ongoing stability, and product quality review inputs. Maintain dossier consistency across regions.
Product Type Considerations
CMC requirements shift significantly by product type. These highlight typical areas that drive additional CMC work and documentation.
Small Molecules
Established pathways, but rising scrutiny on impurity control, including nitrosamines and elemental impurities, and a robust control strategy.
Polypeptides, Polynucleotides & Oligosaccharides
Challenging synthesis and purification, tight control of starting materials, and specialised analytics to demonstrate identity, purity, and impurities.
Combination Products
Integration of drug and device documentation (e.g., extractables/leachables and usability-related elements) into a consistent submission package, including EU MDR Article 117 considerations where relevant.
Biologics & ATMPs
Strong focus on comparability, raw material and cell bank control (as applicable), and extensive characterisation and stability strategy. Regional requirements can differ (e.g., GMO-related handling).
Herbal / Semi-Synthetic Products
Higher variability in raw materials and supply chains, requiring clear standardisation, specifications, and traceability to ensure batch-to-batch consistency.
Depot / Long-Acting Formulations
Control of release profile and batch consistency, alignment between in vitro and clinical performance expectations, and clear bridging justification when formulation, site, or delivery device changes.
Sample Deliverables
CTD Module 2.3 and Module 3 authoring and compilation (phase-appropriate). 
IMPD/IND Quality sections ready for CTA/IND submission, including QbD-based risk assessments where applicable. 
Active Substance Master File / Drug Master File packages (EU, US, Japan, and other ICH regions) plus EU Certificate of Suitability (CEP) dossiers. 
Vendor risk assessment, qualification, audits, and review of quality agreements throughout the supplier selection process in all phases of development. 
Input and review of process and analytical validation protocols and reports. 
Stability protocols and reports aligned to ICH expectations (including climatic zone considerations and regional supply chain needs). Example Projects
Illustrative Example
Mid-Size EU Biotech: Nitrosamine Risk Mitigation
When new nitrosamine guidelines threatened to derail an ongoing Phase III program, we designed a risk assessment, re-validated analytical methods and updated the CTD. The revised dossier was accepted, avoiding a clock-stop.
Illustrative Example
US Biotech: Cross-Regional IMPD and ASMF Preparation
We built a harmonised CMC package for an ATMP, preparing an ASMF for the API, authoring the EU IMPD and aligning it with a parallel IND filing in the US. The sponsor gained approvals in both regions within six months of each other.
Need Hands-On CMC Support?
Let’s discuss your situation and timelines and we will see how we can best help.
Speak with an ExpertKey Regulations & Guidance
Pharmaceutical development is shaped by a range of evolving regulatory expectations, especially when aligning product quality data with various submission requirements. The following guidelines frequently inform our work.
Frequently Asked Questions (FAQ)
What's the difference between pharmaceutical development and CMC?
"Pharmaceutical development" can mean the full end-to-end journey from a candidate compound through nonclinical and clinical development to approval. It can also mean the specific "Pharmaceutical Development" section in the CMC dossier (CTD Module 3). On this page, we use the term in the CMC sense: the work to develop drug substance and drug product, and to turn it into a submission-ready package. CMC is the set of data, controls, and documentation that makes that development work approvable and inspectable.
When should I start planning CMC activities?
As early as possible. Defining your TPP and CQAs in the Discovery phase prevents costly redesigns later.
Do you write and submit dossiers or just advise?
We take full ownership: we author, review, publish, and submit IMPD/IND and CTD Modules, and manage agency interactions.
Can one set of data satisfy both EMA and FDA?
Often yes, but presentation and emphasis differ. We harmonise data generation while tailoring dossiers to regional expectations.
How do you handle vendor changes mid-development?
We perform gap analyses, qualify new vendors, oversee tech transfers, and update regulatory documentation to reflect changes.
What types of pharmaceutical products do you support?
We support a broad spectrum including small molecules, biologics, ATMPs, herbal products, and drug-device combination products. Our team has experience with chemically synthesised APIs, biotechnological substances, peptides, oligonucleotides, and complex formulations.
What if my CDMO's documentation isn't submission-ready?
We often work with CDMO- or sponsor-generated data that needs refinement. We can assess gaps, realign content to regulatory expectations, and rewrite for consistency and clarity to avoid rework at the submission or review stage.
Do you act as EU ASMF representative?
Yes. We prepare and submit ASMFs/DMFs and can serve as the official EU regulatory representative for ASMFs.
Can you manage pharmaceutical development across multiple regions?
Yes — either internally or via the involvement of our global network regulanet®.
How do you support GMP compliance during development?
We embed GMP compliance throughout all phases — from initial process design to IMP manufacturing and commercial scale-up. Services include vendor qualification, GMP-aligned process development, risk-based quality planning, and documentation compliant with EU GMP Annex 13, ICH guidelines, and FDA expectations.
Do you assist with IMPD and CTD Module 3 authoring?
Yes. We provide complete authoring, review, and lifecycle management of regulatory documentation, including IMPDs, INDs, and CTD Modules 2.3 and 3. We also prepare ASMFs, DMFs, and CEP applications to support product registration across ICH regions.
Do I need an ASMF, CEP, or DMF for my drug substance?
That depends on your substance, manufacturing setup, and target regions. We assess whether a third-party file is needed, help prepare the required documentation, and can act as your EU representative for ASMF submissions or CEP applications via EDQM.
Can you support drug-device or packaging decisions?
Yes. We help with selection and compatibility of devices and primary packaging, especially for parenterals and combination products. We can also support usability testing, extractables/leachables, and integration into CTD or technical documentation.