90 + Regulatory affairs experts globally
Our experts work with interdisciplinary teams to provide proven regulatory strategies, manage agency interactions, and support post-approval submissions.
160 + INDs/IMPDs
We consistently deliver high‑quality IND and IMPD enabling CMC dossiers for biologics across global markets.
50 + Biological license applications (BLA/MAA)
We also have experience supporting the CMC dossiers of biological license applications including those with breakthrough or PRIME designations.
100 % Success rate
Achieved in delivering CMC sections for IND, IMPD, BLA, and MAA applications.

Regulatory expertise that drives your molecule’s success

Expert support for your CMC journey

Building a strong CMC package requires scientific insight, regulatory expertise and a clear phase-appropriate strategy. We tailor our support to each milestone from IND/IMPD preparation to BLA/NDA/MAA submissions – ensuring you have the right level of support at every stage.

Our team helps ensure submissions are complete, compliant, and positioned for success in global markets including Europe, the US, Japan, Brazil, Canada, and China. We support accelerated programs such as FDA expedited pathways and EMA PRIME (Priority Medicines) as well as conditional MAs.

Bringing your data together across the lifecycle

Our experts bring together the right data at the right time – from early development through to commercialization. We collaborate closely with development, R&D, quality, MSAT, and analytics teams to meet the scientific and regional expectations that shape IND, IMPD, BLA, and MAA success.

End‑to‑end CMC biologics regulatory affairs services

We work closely with you to provide comprehensive, lifecycle-focused regulatory assistance for biologics.

Our regulatory experts bring broad experience in operations, QA, QC, and process development, helping you understand and meet regulatory requirements for your biologics programs.

We support preparation, authorship, and review of CMC sections for:

  • IND / IMPD submissions
  • BLA / NDA / MAA filings
  • Post‑approval regulatory maintenance including variations and lifecycle updates

Our global experience with agencies such as the EMA, FDA, PDMA, TGA, NMPA, Health Canada, and ANVISA, allows us to deliver timely and informed support.

Biologics regulatory strategy

Our team helps you avoid submission delays by preparing complete, well‑structured filings that meet health authority expectations. We support each critical milestone as your molecule advances toward commercialization and help identify the documentation required for successful submissions including PPQ and validation data.

We also anticipate regulatory questions, prepare for agency interactions and support health authority meetings. Our integrated approach reduces friction and empowers you to move confidently from discovery through commercialization.

Webinar: Navigating the CMC regulatory landscape

Through case studies and practical examples, this webinar explores complex regulatory requirements for developing and commercializing protein-based medicines, focusing on Chemistry, Manufacturing, and Controls (CMC). Discover an approach that emphasizes cross-functional collaboration, strategic planning, and regulatory intelligence to guide clients through submissions, lifecycle changes, and inspections, ensuring alignment, compliance, and timely approvals in a shifting regulatory landscape.

Learn more in our on-demand webinar
Frequently Asked Questions

We support regulatory submissions for both biologics drug substance and drug products across clinical and commercial stages. Our team prepares, authors, and reviews CMC sections for IND and IMPD applications, as well as BLA, NDA, and MAA submissions. We also support post‑approval maintenance, including variations and lifecycle updates, and work closely with global health authorities.

Our experts stay aligned with global regulatory expectations and anticipate differences across agencies. We prepare submissions that reflect current guidelines and support science‑driven and expedited regulatory pathways. This helps you move efficiently from early clinical development through commercialization while staying prepared for regulatory interactions.

Our global team includes more than 90 regulatory affairs experts and has delivered more than 160 IND/ IMPD applications and more than 50 BLA/MAA filings, including expedited submissions. We have achieved a 100% success rate in delivering CMC sections for major submission types.

We recommend engaging early to align development plans with long‑term regulatory expectations. Ongoing support through clinical development, commercialization, and post‑approval changes ensures efficient submissions, timely responses, and effective lifecycle management.

We provide end‑to‑end CMC regulatory support for biologics bringing together technical, scientific, and regional data at every stage. Our interdisciplinary approach ensures your submissions are complete, compliant, and ready for global review.

Yes. We have extensive experience supporting expedited pathways such as FDA Fast Track, Breakthrough Therapy, and Priority Review, EMA Prime, and MHRA ILAP. We provide phase‑appropriate CMC strategy, authoring, and agency‑interaction strategy, to help you meet accelerated timelines.