Navigating diverse regulatory environments
To facilitate seamless extension of clinical studies, across borders.
The arduous path from bench to bedside is chock-full of complexity, copious resource demands, and considerable costs—yet each and every pharmaceutical product out there must endure the same before making its grand entrance into the marketplace. The global regulatory landscape, with nuances of its own, further compounds these challenges.
The CliniRx team is well-versed in these regulatory hurdles and therefore well-equipped to offer bespoke, product-centric regulatory solutions aligning with sponsor expectations re: cost, time, and quality. In doing so, our highly skilled regulatory professionals work side-by-side with sponsors to lay out strategic regulatory paths for pharmaceutical products including drugs, biologics, medical devices, and cosmetics. Always putting our in-depth regulatory knowledge and understanding of this machinery to good use, CliniRx provides sponsors with transparent perspective regarding regulations across various geographies to dispel any uncertainty.
At a more granular level, our Regulatory Affairs services span a comprehensive range of clinical trial and post-marketing offerings including:
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Global Regulatory and Scientific Advice
We devise regulatory strategies and execute meetings at all developmental stages, weaving in preclinical, pharmacology, CMC, and clinical components.
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Full Clinical Trial Life Cycle Service (Preparation, Application, Post-Approval Maintenance, and CSR Submission)
- We develop regulatory strategic plans re: clinical trials authorization processes for submissions to competent authorities and ethics committees (Phase I to Phase IV) and/or observational studies, medical devices, or nutrition products.
- We review required regulatory documents for completeness and accuracy (e.g., study protocol, IMPD, IB, IMP labels, ICF, and import/export licenses).
- We prepare submission packages and manage submissions (electronic or otherwise), adhering to applicable requirements.
- We support compliance assurance efforts per relevant local or international guidelines and standards.
- We provide end-to-end support for various submissions including protocol/IB amendments, change of site/principal investigator, and registration.
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Country-Specific Registration
We facilitate registration on national websites and/or ICMJE registries (e.g., clinicatrials.gov) in compliance with country-centric requirements.
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Safety Reporting
We undertake safety reporting practices (e.g., DSUR & PSUR submissions) and expedited, periodic reporting (EudraVigilance, MHRA, FDA, and TGA) for key global geographies.
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Program Review and Regulatory Management
We oversee the entire product life cycle from regulatory strategy development to agency communication for first-cycle approvals and license renewals.
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eCTD Submission
We ensure a seamless process for the eCTD (electronic Common Technical Document) creation, publishing, and submission.
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Consulting
We provide tailored planning and strategic guidance in lockstep with sponsor expectations.
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Local Applicant Support
We offer comprehensive regulatory support in key geographies, collaborating with legal and registered entities.
In executing all of the above endeavors, CliniRx stands as your dedicated partner organization and is fully committed to delivering quality solutions while supporting you throughout the entire regulatory life cycle.
Experience supporting small Biopharma bring New Drug to Market!
We’ll be happy to discuss further.
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