Expert CMC Regulatory Affairs Services

What we do

CMC Strategy and Regulatory Submissions: Development of regulatory strategies and preparation of high-quality CMC documentation for IND/IMPD submissions, ensuring smooth progression through clinical trial phases I-III.
Technical Writing and Gap Analysis: Preparation of IND / IMPD and technical documentation, ensuring alignment with clinical trial goals.
Manufacturing and Quality Oversight: Guidance on manufacturing processes, analytical methods, and quality control to ensure compliance with regulatory standards and support scalability for clinical and commercial needs.
Regulatory Intelligence and Agency Interactions: Expert navigation of global regulatory requirements and representation in regulatory agency meetings, including Scientific Advice or Pre-IND discussions.
Lifecycle and Compliance Management: Support for post-approval changes, gap analysis, and resolution of deficiencies to maintain compliance throughout the product lifecycle.

The RA Impact Client Case Studies

Supporting a Clinical-Stage Radiopharmaceutical Client

Challenge: The client required regulatory support to prepare and submit an IMPD and IND for their clinical trial.

Solution: Developed a tailored IMPD and IND addressing radiopharmaceutical-specific regulatory requirements and proactively resolved FDA and EMA questions.

Result: Regulatory approval was secured within the target timeframe, enabling the client to initiate their trial without delays.

Enabling a Novel Extended-Release IMPD and IND Submission

Challenge: A mid-sized pharma company needed expertise in authoring regulatory documents for an extended-release drug.

Solution: Partnered with development teams to assess risks, define a technical strategy, and draft the IMPD and IND to align with regulatory expectations while ensuring development flexibility.

Result: Both submissions were accepted promptly, keeping the clinical program on schedule.

Accelerating Approvals for a new Vaccine Manufacturing Site

Challenge: The client sought regulatory approval for a new vaccine manufacturing site to meet pandemic-driven timelines.

Solution: Designed an accelerated three-phase regulatory strategy, engaged with MHRA for scientific advice, and aligned the strategy to address key concerns.

Result: The MHRA approved the proposed approach, ensuring regulatory clearance in time to meet critical seasonal demand.

Registering a Chinese API Client’s First ASMF with EMA

Challenge: The client faced challenges preparing a compliant ASMF for their first EMA submission.

Solution: Conducted a comprehensive gap analysis to identify weaknesses, provided targeted technical guidance, and developed a risk mitigation plan to strengthen the dossier.

Result: The ASMF received approval with minimal regulatory queries, ensuring a smooth and timely process.

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