Integrated CMC Dossier Preparation for Global Regulatory Approval
We prepare and support CMC sections of INDs, IMPDs and equivalent global submissions, aligned to current expectations of the MHRA, EMA and FDA. Our regulatory specialists work hand-in-hand with development, analytical, manufacturing and quality teams to ensure dossiers accurately reflect the science, the process and the control strategy.
Preparation, authoring and review of CMC Modules for Drug Substance and Drug Product
Phase appropriate CMC strategies aligned to your clinical development plan
Compilation of dossiers directly from primary source data
Review and remediation of existing CMC documentation
Support with regulatory questions, RFIs and agency interactions
Ongoing lifecycle support as your programme progresses
Why It Matters That We Write the Dossier
Direct access and regulatory alignment
Immediate access to raw data, batch records, and subject matter experts ensures dossiers accurately reflect real GMP operations, controls, and change management.
Faster timelines with lower overall cost
Integrated authoring avoids the delays, duplication, and miscommunication often associated with third party dossier preparation.
Reduced regulatory risk
Early identification and resolution of gaps, inconsistencies, or compliance risks before submission.
We embed regulatory thinking early to avoid downstream rework and delays, including:
- Phase appropriate Drug Substance and Drug Product specifications
- Alignment with ICH Q11 for regulatory starting material selection
- Development of robust impurity control strategies
- Early identification and mitigation of Potential Mutagenic Impurities (PMIs) in line with ICH M7
- Risk assessments for nitrosamine impurities
- Data generation that supports both early clinical supply and future lifecycle progression
Impurity and Risk Based Assessments:
- PMI classification, control strategy definition and specification setting
- Nitrosamine risk evaluations across raw materials, processes and excipients
- Integration of analytical, process and regulatory controls into a coherent CMC strategy
- Third‑party in silico mutagenicity assessments, delivered through established partner tools
- Where required, we can also support rapid AMES testing through trusted partners to strengthen regulatory confidence.
Arcinova: Proven Experience You Can Rely On
34 CMC modules successfully submitted in 2025 across DS, DP and placebo
Only one regulatory request for information (RFI)—resolved quickly