Regulatory Services
Moving biologics from the bench into the clinic and on to market approval requires thorough understanding of the available regulatory pathways, excellent relationships with regulatory authorities, and transparent communication across the project team.
We have the expertise to help you navigate complex global regulatory processes, advancing your program into the clinic and through to approval.
Scientifically sound regulatory solutions to accelerate R&D of innovative drugs
We specialize in supporting small, virtual start-ups, and innovative drug development companies like yours, we give you the with regulatory guidance and expertise and experience to accelerate your life-changing new therapies through to regulatory approval.
As the key interface between regulatory authorities around the globe and the project team, we work closely with you to anticipate requirements early utilizing strategic advice meetings and best practices from our experience.
From the US FDA to Europe’s EMA to China’s CDE, our team has developed strong working relationships and has a deep understanding of the agencies’ requirements and how to interpret these appropriately for your project.
We’ve helped our partners develop strategies across a wide range of therapeutic applications, including novel programs where little to no guidance exists. We are experienced in a variety of products including chemical drugs, large molecules, vaccines, cell and gene therapy (CGT) products and medical devices.
From strategy to regulatory writing for trial and marketing applications, we give you access to collaborative expertise and a deep understanding of global regulatory requirements. Our experts know what data are needed and how to generate and capture them appropriately across each clinical phase to support successful NDAs, IND filings and BLA submissions.
Regulatory Affairs
Submission Writing and Regulatory Strategy
Across our clinical experience, we’ve developed strategies to support clinical trials for global regulatory bodies including the FDA, EMA, CDE and more.
We understand the requirements and complexities of the FDA’s special designations for breakthrough drugs, fast-track medicines, orphan disease treatments and the 505 (b)(2) pathway and we can help you on your journey to securing accelerated approval status.
In addition, we have an in-depth understanding of NMPA and CDE requirements in China, with a robust team of regulatory professionals committed to taking advantage of China’s changes to bring their regulatory system in line with international standards, accelerating the IND and NDA approval process.
We support your clinical needs in four key areas:
- Submissions: We are experienced in managing IND, CTA, NDA (505 (b)(1) and 505 (b)(2), BLA, DMF, ANDA and MAA submissions, with over 1,000 electronic submissions per year.
- Special Designations: We regularly manage special designation requests such as orphan, fast track, breakthrough, rare pediatric disease designation, PRIME, pediatric plan, priority review.
- Strategy and Meetings: We recommend and participate in strategic advice meetings in the pre-IND, end of Phase I, end of Phase II, Pre-NDA/BLA, scientific advice, and special protocol assessment (SPA); and we support your clinical and marketing development strategy, due diligence, and provide regulatory intelligence and strategic assessments.
- Dossier and File Maintenance: We maintain dossiers and files for over 80 active INDs annually, as well as multiple CTA, DMF, ANDA, NDA, BLA, and MAA files.
Non-Clinical
We can also support you across your non-clinical studies by examining your animal and lab data to determine your drug’s safety in human trials.
We deliver:
- Non-clinical strategy
- Study lab identification, study set up, and study monitoring
- Review of non-clinical reports (for Module 4), data interpretation, and writing of study reports
- Writing of Module 2.4 and Module 2.6
- IB guidance to investigators, starting dose justification
- IND-enabling non-clinical studies (ADME, PK, safety pharmacology, genotoxicity, non-GLP and GLP toxicology)
- Tox studies; drug supplies, vendor identification/qualification, audits, manufacturing scale-up, analytical development
- Regulatory agency meetings, responses, and liaison services
- Type II drug master files (DMF)
CMC Strategy and Writing
Our experts have extensive experience in managing all Chemistry Manufacturing and Controls (CMC) activities for academic and virtual sponsors, including onsite support for your critical operations.
We can provide you with expertise in small molecules, proteins, antibody-drug conjugates (ADCs), cell, tissues, and gene therapies (CGTs) and more, providing guidance to sponsors to ensure regulatory compliance for cell banks and specifications, manufacturing requirements, analytical testing strategy and methods, and facility requirements.
We deliver:
- Phase specific strategic consulting
- Process controls, specifications, and formulation assistance
- CMC project management
- Writing Module 2.3 and 3 documents
- CMO selection and management
- Supply chain coordination
- CMC audits
Personalized clinical research services
Across every stage of your clinical journey, we’re by your side to help you advance through clinical trials to get your therapy to patients and help bring your science to life.
Speak to a global expert
Start your journey on the path to regulatory approval with the expertise and experience of Caidya’s regulatory experts. Together, we can reach patients and improve lives.
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