Regulatory CMC
Science-Based | Risk-Based | Strategic/Tactical | Customized
The continuously evolving CMC regulatory landscape presents a steady challenge to the development of new drugs, therapies, and devices. For example, regulator’s expectations to adopt new paradigms of drug development (e.g. QbD/PAT) and increased testing and controls can add major CMC challenges in the current climate of globalized and outsourced R&D and manufacturing settings. The opportunity for expedited regulatory pathways poses additional CMC challenges for the timely development of a commercial-ready process.
These scenarios are further confounded by the lack of harmonized global regulations. At Syner-G, we have extensive experience in navigating this landscape and are passionate in helping our clients in the design, planning, and execution of CMC strategies that are critical for the successful development and timely approval of new drugs.
Our Regulatory Solutions
Typically, regulatory activities follow the 80:20 rule, i.e. 80% are tactical and 20% are strategic. Syner-G offers both strategic and tactical CMC solutions. Strategic CMC regulatory solutions are designed on a case-by-case basis by evaluating the scientific and technical situation and challenges, whereas tactical solutions are primarily geared towards the execution of the strategy.
Strategic CMC Services
- Define the “right content” for all regulatory submissions
– Investigational applications (IND/IMPD/CTA/CTX)
– Marketing applications (NDA/MAA/NDS)
– Type II Drug Master Files (DMF) - Manage critical quality issues during development
– Genotoxic impurities/degradants, stability
– Material/process controls, specifications
– Formulation/process changes during development - Change management
– Investigational stages
– Post-approval stages - Regulatory agency meetings (Pre-IND, EOP-2, Pre-NDA, Type C, Scientific Advice)
- QbD: commercial product/process/control-strategy
- Responses to regulatory agency inquiries
- CMC regulatory due-diligence (for in-license or out-license)
Tactical CMC Services
- eCTD documentation (Module 3/Module 2.3 QOS)
– Investigational applications (IND/IMPD/CTA) and amendments
– Marketing applications (NDA/BLA/MAA/NDS)
– sNDA (post-approval PAS or CBE)/variations
– Type II Drug Master Files (DMF) - Annual report documentation
– INDs
– NDAs
– BLAs
– DMFs - CMC submission project management
- Regulatory submissions
- Liaison services with regulatory agencies
- CMC regulatory conformance gap analysis and remediation
- CMC annual product review
- CMC report writing (development, stability, validation)
Why You Should Choose Us
Whether you seek expert regulatory consulting advice for regulatory starting materials selection, identifying control strategies for genotoxic impurities, or help in strategizing and preparing briefing documents or CTD Modules 3 and 2 of regulatory submissions, we have qualified professionals to support your specific regulatory requirements. Our staff comes from the pharma industry and the FDA, with proven expertise in all areas of CMC Regulatory Affairs to support global clinical trials and market authorization applications. We are adept in designing phase-appropriate and product-specific CMC strategies that are the key to successful and expedited drug development.
Headquarters
100 Pennsylvania Avenue, Suite 310
Framingham, MA 01701
Contact Us
508.460.9700
info@synergbiopharma.com