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Regulatory
Our regulatory experts provide comprehensive support throughout your product’s lifecycle, ensuring compliance with global regulations and standards, enabling you to manufacture more tomorrows.
A strategically-minded approach
Backed by a rich regulatory heritage and an extensive understanding of FDA and EMA requirements, our team provides strategic guidance and can manage all your regulatory needs, from pre-marketing to post-marketing strategies.
An experienced team
Former regulators and industry specialists skilled in dossier preparation, global regulatory submissions and strategic regulatory planning for products in all stages of development.
Global regulatory knowledge
Current knowledge of global regulations and guidelines ensures your submissions align with best practices.
Proactive monitoring
We closely monitor the evolving regulatory landscape to identify risks and proactively implement effective mitigation strategies.
Submission excellence
High-quality submissions that meet strict regulatory deadlines, with meticulous attention to format, messaging accuracy and consistency across all documents.
Comprehensive support
We support all types of submission applications using a cost-effective, right-first-time approach.
Delivering exceptional regulatory value
Customized regulatory expertise tailored to your specific needs, ensuring success across the global regulatory landscape.
- Global reach: Extensive experience navigating the regulatory frameworks of North America (U.S. and Canada), Europe and the U.K., China and Latin America.
- Licensing and compliance: Expertise in controlled substances licensing and materials certifications for import/export, ensuring seamless operations and compliance.
- Proven track record: Regulatory firsts, including the first HFA product approval in the U.S. (Proventil), the first generic combination pMDI product approval in the EU and U.K. (Sirdupla/Aloflute), and the first generic combination pMDI product approval in the U.S. (Breyna™).
Regulatory services designed to help you progress with purpose
We provide comprehensive regulatory support, including strategic guidance, submission management and expert advice on evolving global legislation to ensure your products remain compliant.
We offer chemistry, manufacturing and controls (CMC) consulting services to optimize drug substance and drug product development, manufacturing and technology transfer processes.
We act as your dedicated liaison in all regulatory agency interactions, providing expert guidance, communication management and strategic planning to ensure productive engagement and successful outcomes.
If your drug product qualifies for expedited approval pathways (e.g., accelerated approval, priority review, breakthrough therapy designation), we provide expert guidance and assist with application preparation, health authority interactions and strategic planning to optimize your expedited review process.
We provide comprehensive labeling services, from development and optimization to full SPL and XML submission support, ensuring your product labeling meets all regulatory requirements.
We provide comprehensive support for your submission dossier preparation needs, including drafting documents, facilitating stakeholder meetings, compiling compliant common technical document (CTD) tables of contents (TOCs) and ensuring meticulous formatting and organization of published documents.
We can expertly manage all your marketing applications (e.g., IND, NDA, ANDA, BLA, MAA), including strategic planning, health authority interactions, project management and preparation of initial and subsequent submissions to ensure compliance with current industry regulations and optimize your approval success across multiple markets.
We can manage your eCTD submissions, ensuring compliance with all guidelines and preparation of submission-ready files, including metadata, links and a comprehensive table of contents. We handle the seamless transmission of your dossier to designated health authorities via authorized portals.
We provide comprehensive assessments, guide your materials through the necessary review committees and manage submissions for both U.S. and global markets to ensure your promotional materials are compliant.
We offer comprehensive support, strategic guidance and preparation for all your supplemental filing needs, including statutory reporting, labeling updates, CMC revisions, Module 1 updates, regulatory project management, waivers and NextGen sales reports.
Related CDMO solutions
From development to commercial manufacturing and beyond, our CDMO solutions are designed to help your product progress with purpose.
Development
Our expert team collaborates with you, leveraging a development-by-design approach to optimize drug formulations and innovative delivery devices.
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Manufacturing
Discover scalable manufacturing solutions, from clinical trial supplies to commercial production, and state-of-the-art manufacturing facilities.
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Analytical
Comprehensive analytical testing and characterization services to ensure the quality, safety and efficacy of your drug products.
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Fill finish
Optimize your drug product fill finish with our state-of-the-art facility featuring high-speed, Annex 1-compliant lines for vials, cartridges and syringes.
Learn moreRegulatory resources and insights
Explore our library of resources to learn more about our regulatory capabilities and expertise.
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Learn MoreLet's transform tomorrow together
Every patient deserves a brighter tomorrow. As your strategic partner, we are dedicated to building your lasting legacy and helping you fast-track healthier tomorrows. You dream it, we deliver it.