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Expert Clinical CMC Regulatory Affairs
Tailored for your needs
Regulatory Submission
Technical Authoring: Expert preparation of eCTD documents (Module 3 and QOS) tailored to drug modality.
Agency Engagement: Strategic preparation for regulatory meetings (Pre-IND, Scientific Advice) to discuss your product's CMC development and clarify regulatory expectations.
Response Management: Effective management of regulatory agency inquiries to facilitate smoother approvals.
Strategic CMC Planning
Regulatory Strategy Development: Designing robust CMC regulatory strategies that account for the unique challenges, ensuring alignment with regulatory requirements at each clinical stage.
Global Submission Expertise: Guidance on preparing key submissions (IND/IMPD/CTA), with a deep understanding of the specific requirements across major regulatory authorities (FDA, EMA, MHRA).
Change Management: Supporting process and formulation changes during clinical development to maintain regulatory compliance and enhance product safety.
Quality and Compliance Assurance
CMC Conformance Gap Analysis: Identifying and resolving compliance gaps to meet evolving regulatory standards.
Annual Reports and CMC Documentation: Comprehensive documentation, including CMC Annual Product Reviews and updates, to support ongoing compliance and build regulatory goodwill.
Supporting Advanced CMC Development
Quality by Design (QbD) Implementation: Employing QbD principles to establish a control strategy that aligns with regulatory expectations.
Due Diligence for Licensing: Conducting CMC regulatory due diligence for in-licensing and out-licensing projects, providing thorough evaluations to ensure regulatory compliance.
Facing urgent CMC challenges or resource gaps?
Partner with Thera Impact to access specialised expertise and strategic support, tailored to ensure your project’s success.
Why Choose Thera Impact?
Proven Track Record: We bring our expertise and insight to your CMC regulatory needs.
Client-Centered Approach: We prioritise clear communication and transparency, ensuring every project stage aligns with your clinical and commercial goals.
End-to-End Support: From strategy development to documentation and submission, The RA Impact is your trusted partner in navigating CMC challenges and achieving timely approvals.
Access to network: Backed by a trusted network of specialized consultants for comprehensive support.
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