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Regulatory services for cell and gene therapy
At OXB, quality and regulatory excellence are central to everything we do. With decades of experience advancing viral vector therapies, we’ve helped bring products to patients worldwide by embedding quality and regulatory foresight into every stage of development and manufacturing. From IND through commercial launch, our team partners with you to anticipate challenges, de-risk programs, and ensure successful engagement with global health authorities.
Why choose OXB for quality and regulatory support?
Our quality and regulatory support includes
Proven experience
30+ successful IND submissions and products approved in 40+ countries.
End-to-end regulatory support
From consultation packages to full authorship of regulatory filings.
Trusted expertise
LentiVector™ platform and inAAVate™ platform processes with demonstrated consistency and scalability.
Assay expertise
55+ in-house assays accepted by FDA, EMA, MHRA, and PMDA.
Global readiness
Strong relationships with regulatory authorities and experience across the product lifecycle.
De-risking development with built-in regulatory expertise
CMC success depends on anticipating and addressing challenges early. OXB embeds regulatory strategy, robust analytics, and platform consistency into every program to minimize risk and accelerate progress.
Addressing common industry challenges
Platform inconsistency risks
→ Our platforms deliver proven comparability and scalability, backed by 30 years of viral vector expertise and 8,000+ patients treated with OXB-based products.
Addressing common industry challenges
Weak or incomplete assays
→ With more than 55 validated assays covering potency, impurities, and structure, we provide the analytical depth needed for regulatory trust and patient safety.
Addressing common industry challenges
Fragmented lifecycle CMC strategy
→ We offer end-to-end support, including IND, CTA, MAA, and BLA submissions, plus ongoing CMC support for comparability and supplements.
Addressing common industry challenges
Unprepared regulatory interactions
→ Our experts prepare and participate in agency meetings, draft quality sections, and provide strategic input to ensure regulatory clarity and confidence.
Addressing common industry challenges
Post-market CMC risks
→ High-sensitivity analytics and scenario planning support product comparability, global change control, and post-marketing commitments.
Partner with OXB for quality & regulatory excellence
Whether you’re preparing your first IND or managing commercial supply, OXB’s integrated quality and regulatory services provide confidence, compliance, and speed to market.
Explore OXB’s other CDMO solutions
Related resources
The TetraVecta™ System: Optimisation & Exemplification of OXB’s Next Generation Lentiviral Vector
View PDF >Enhancing Titres of Therapeutic Viral Vectors using the Transgene Repression in Vector Production TRiP System
This paper describes using a TRiP system to temporarily repress transgene expression during production, boosting viral vector titers for therapeutic use.
View PDF >Frequently asked questions
OXB embeds regulatory foresight and robust quality systems into every stage of development. By addressing comparability, assay robustness, and lifecycle strategy early, we help partners avoid common CMC pitfalls that can delay approvals.
Unlike many CDMOs, OXB offers modular regulatory work packages—from expert consultation to full authorship. We actively participate in agency meetings, provide strategic input on process development, and support filings across IND, CTA, MAA, and BLA.
OXB has supported over 30 IND submissions, 2 MAA submissions, and maintains strong relationships with agencies worldwide. Products manufactured with OXB-based vectors are approved in more than 40 countries, treating over 8,000 patients.
We offer 55+ in-house assays covering potency, impurities, and structural integrity. These assays are validated, regulatory-accepted, and critical for demonstrating product quality, comparability, and patient safety.
Our lifecycle services include comparability assessments, change control management, stability testing, and ongoing CMC support, and authorship and support of post approval submissions. We also provide scenario planning for post-market commitments to help mitigate long-term regulatory risk.
Our regulatory team is made up of specialists with decades of experience in CMC strategy, agency engagement, and global submissions. They bring a proactive, solutions-oriented mindset, ensuring every program benefits from both scientific rigor and regulatory foresight.