Expert Regulatory Support for Biologics Development
At Olon, we understand that navigating the regulatory landscape is one of the greatest challenges in biologics development. Success depends on more than robust science — it requires a well-planned regulatory strategy, flawless documentation, and proactive communication with authorities worldwide.
Global Expertise in Biologics Regulation
Our regulatory affairs specialists work hand in hand with your team, providing expertise that spans EMA, FDA, and global agency expectations. With more than two decades of experience, we help you anticipate requirements, avoid costly delays, and accelerate your path to patients.
Our regulatory team combines deep scientific knowledge with practical experience in CMC strategy and regulatory submissions. Working across operations, QA, QC, and process development, we ensure that every element of your dossier reflects the latest guidance and best practices.
Hands-on experience with EMA, FDA, and other global agencies
CMC-focused strategy integrated into development programs from the start
Regulatory intelligence to keep projects aligned with evolving expectations
Support across a wide range of biologics: antibodies, recombinant proteins, conjugates, and vaccines
Comprehensive IND & IMPD Filing Support
Preparing regulatory dossiers is complex and resource-intensive. At Olon, we streamline the process by embedding regulatory expertise into every stage:
Integration of quality and process documents into IND/IMPD submissions
In-line document review to avoid gaps and minimize agency questions
Regulatory writing and editing for CMC modules and related sections
Guidance on submission strategy to shorten approval timelines
Our proactive approach ensures that you enter clinical trials with confidence, supported by well-prepared, regulatory-compliant documentation.
Support Across the Biologics Lifecycle
Regulatory support at Olon doesn’t end with early-phase submissions. We remain by your side throughout development and beyond:
Early development – advice on regulatory pathways and risk mitigation
Clinical stages – dossier updates, CMC strategy alignment, and smooth scale-up documentation
Commercial readiness – preparation for BLA/MAA filings and global market entry
Post-approval – lifecycle management, change control documentation, and ongoing compliance
This continuum ensures your biologic maintains regulatory integrity and market access throughout its lifecycle.
Partner with us today and ensure seamless regulatory compliance for your biologics!
Partner with GTP Bioways CDMO for seamless transitions and unlock success in your biotherapeutics development journey!
