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.
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.
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:
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:
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:
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.
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.
Explore our news and updates as we liberate the clinical research process.
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07/22/2024
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06/12/2024