Regulatory Affairs & CMC Services
Are you developing a new drug product and thinking about the next regulatory relevant steps for your candidate?
At GxPerts, we understand that it is essential to have a good regulatory and CMC strategy in place for the clinical development of a new drug substance (API) and drug product.
Strategic RA & CMC Guidance – From Preclinical to Market
We know about the challenges and regulatory and CMC requirements to be fulfilled for drug substance(APIs) and drug products in the clinical development, based on our more than 35 years experience in the pharmaceutical industry and 20 years experience in drug substance CMC development in a CMO / CDMO with customers from the pharmaceutical and bio-pharmaceutical industry, startups, medium sized companies and big pharma.
We understand that each company has its specific challenges, and we can help you to define the CMC strategy for your development project from pre-clinical through the clinical phases up to launch and commercialization.
Our service at GxPerts is about tailored solutions considering the status of your project including the available dossiers and documentation and finding a good balance between the regulatory needs, pragmatism and your requests and economic circumstances.
Regulatory Affairs and CMC
Understanding the regulatory and CMC challenges and requirements in the clinical development is key for a successful pathway forward and up-coming submission and for responding the inquiries from the authorities. A professional early strategic thinking in advance concerning the subsequent steps and an up-coming IND / IMPD and NDA submission is essential. Our service offers customized regulatory and CMC strategies as well as ensuring regulatory compliance and review and maintenance of dossiers.
End-to-End CMC Consultancy
We support your CMC process and product development from preclinical to commercial stages. This includes strategic planning, hands-on guidance, and detailed CMC gap analyses for modules 3.2.S and 3.2.P—ensuring all elements meet regulatory expectations.
Global Regulatory Coordination
We help define your corporate CMC standards and coordinate regulatory activities across departments and international sites. Our service ensures consistency and alignment throughout your global development efforts.
Internal Compliance Frameworks
We assist in establishing and maintaining internal compliance standards for regulatory processes. This ensures your organization is always audit-ready and operating in accordance with evolving regulatory expectations.
Dossier Review & Maintenance
We offer ongoing support in reviewing, updating, and maintaining your regulatory dossiers. This service ensures continuous data integrity and timely submission readiness throughout the product lifecycle.
Martin Schneider
CEO & Founder of GxPerts
Dedicated to your success
in GxP for over 25 years
Hands-On
operational Excellence
Direct involvement in Quality Assurance, including FvP roles, with adeptness in managing Quality Systems, Control, Analytics, and ESH. Combining hands-on expertise with managerial excellence in Regulatory Affairs and CSV for comprehensive operational success.
Qualified Auditor for all
international GxP standards
Auditing experience in Europe, China, India Korea and Taiwan.
Strong Service
Mentality
Experience for CMOs and CDMOs in GXP environment, for Drug Products, Drug Substances and Cosmetics.
Compliance Remediation
Strategist
Developed the strategy for and lead the remediation activities after a statement of non-compliance or a warning letter
International Compliance
Success
Proven success in preparing and managing manufacturing sites for global authority inspections, including SwissMedic, FDA, EMA, EDQM, PMDA, MFDS, ANVISA and others.
Versatile Client Portfolio
With extensive GxP experience, we serve a diverse range of clients cross pharmaceuticals, biotechnology, and cosmetics industries, while maintaining strict confidentiality.
“In regulatory and CMC matters, clarity and timing are everything. Let’s discuss your next step – I’d be happy to support you.”
Send me a message!
Ready to elevate your compliance and operational excellence? Reach out today to discuss how we can achieve your GxP goals together!