Diagnostics
Our CMC Development & Manufacturing division ensures a seamless transition from laboratory innovation to commercial-scale production. We focus on Chemistry, Manufacturing, and Controls activities that underpin regulatory approvals and long-term product success.
We manage CMO/CDMO/CRO partners, oversee cGMP Manufacturing, Process Design, Scale-up and Validation, and prepare complete Regulatory documentation (IND/IMPD/NDA/BLA/MAA/eCTD/DMF) so your program advances on time and in full compliance.
Comprehensive CMC Capabilities
We provide integrated CMC solutions from pre-IND through commercialization — spanning Analytical Methods, Manufacturing, Documentation, and Global Compliance.
- CMC strategy development aligned with FDA, EMA, GHC, MENA, DRAP, MHRA and SFDA expectations.
- CMO/CDMO/CRO identification, qualification, contracting, and management.
- cGMP Manufacturing oversight from pilot to commercial scale.
- Process design optimization (QbD), and Technology Transfer.
- Analytical Method Development, Validation, and Lifecycle Management.
- Batch Records, Stability Programs, and Quality Documentation.
- Preparation of CMC modules for IND/IMPD/NDA/BLA/MAA/eCTD/DMF submissions.
Process Design & Optimization
Design robust, scalable processes using QbD principles and statistical modeling for reproducibility and cost-efficiency.
Scale-Up & Validation
Plan and execute Pilot, Engineering, and Validation batches to meet cGMP requirements and ensure process consistency.
CMO/CDMO/CRO Management
Select and oversee global partners to ensure transparency, quality, and on-time delivery across all manufacturing stages.
Our Approach
We integrate Science, Engineering, Quality, and Regulatory CMC frameworks so your product is designed for manufacturability, compliance, and scale.
- Cross-functional alignment between R&D, Manufacturing, and Quality.
- Implementation of ICH Q8–Q12 guidelines with Data Integrity and QMS controls.
cGMP Manufacturing
Execute Pilot, Engineering, and Commercial batches with full traceability and release testing under GMP oversight.
Quality Asssurance
End-to-end support for manufacturing, quality and regulatory compliance.
CMC Partnerships & Global Manufacturing Network
We collaborate with trusted CMO, CDMOs, CROs, and certified testing laboratories to deliver cost-effective, compliant, and timely CMC solutions.
Technology Transfer
Handover from Development to Manufacturing with Validated Processes, Methods, and Materials.
Regulatory CMC Support
Preparation of CMC modules for IND/IMPD/NDA/BLA/MAA/eCTD/DMF submissions with inspection readiness.
Quality & Compliance
Continuous cGMP compliance via robust QMS, CAPA, and periodic audits.
Frequently asked questions about CMC
CMC (Chemistry, Manufacturing, and Controls) includes process design, analytical methods, GMP manufacturing, stability, and documentation required for regulatory submissions.
We plan and execute Technology Transfer with defined CPPs/CMAs, equipment qualification, method validation, and knowledge transfer packs.
Depending on complexity, CMC readiness for IND can range from 6–12 months, covering process development, analytics, and initial stability.
Through QMS implementation, vendor audits, CAPA tracking, change control, and continuous monitoring aligned with ICH Q10 and Annex 15.
Yes. We shortlist, contract, and manage CMO/CDMOs/CROs with KPI tracking, risk registers, and clear governance for timelines and quality.