The regulatory approval of therapeutic and diagnostic products is a science-driven process. Complex and nuanced scientific discussions with regulatory agencies for precision medicine products take time. These discussions also need to be strategically integrated with prescriptive pathways (i.e., NDAs, IDEs) for regulatory approval. How early should sharing of scientific ideas, concepts and data with regulatory agencies start? How well do prescriptive pathways capture the regulatory context of novel precision medicine products?
Regulatory Pathfinders is a consultancy for therapeutics and in vitro diagnostics. Its focus is on regulatory strategy design and development for companion diagnostics, combination products, and other medical products requiring complex and/or novel regulatory pathways. This focus is drawn from broad experience in the application and regulatory acceptance of patient selection biomarkers, companion diagnostics, alternative endpoints and surrogate biomarkers for clinical trials.
Company Details
- Employees
- 1
- Founded
- -
- Address
- 7 San Carlos St, San Juan,puerto Rico 00926,puerto Rico
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Keywords
- Biotechnology, Companion Diagnostics, Oncology Therapeutics, Alzheimer's Therapeutics, Rare Diseases, Rheumatoid Arthritis Diagnostics, Lupus Diagnostics, Oncology Diagnostics, qPCR, NGS, FDA, Regulatory Affairs, Biomarkers, Surrogate Endpoints, Patient Selection Markers.
- HQ
- San Juan, Puerto Rico
- Competitors
- HTG Molecular Diagnostics, Regulatory Services, ATTOPOLIS@ARQon-Asia Regulatory & Quality Consultancy (MedTech & Drug), Pep2Tango Therapeutics, Vasomune Therapeutics, Inc., MID Gulf Investments, IMed Consultancy Ltd, ECTI Ain-Rhône - Association de bénévolat senior compétences, Pharmozyme Inc, Acorn Regulatory Consultancy Services Limited.
Regulatory Pathfinders, Llc Questions
Regulatory Pathfinders, Llc's website is http://www.regulatorypathfinders.com
Regulatory Pathfinders, Llc's LinkedIn profile is https://pr.linkedin.com/company/regulatory-pathfinders-llc
Regulatory Pathfinders, Llc has
1 employees.
View email and phone details for 1
employees at Regulatory Pathfinders, Llc.
Regulatory Pathfinders, Llc's industry is
Biotechnology Research
Regulatory Pathfinders, Llc's top competitors are
Htg Molecular Diagnostics,
Regulatory Services,
Attopolis@arqon-Asia Regulatory & Quality Consultancy (Medtech & Drug),
Pep2tango Therapeutics,
Vasomune Therapeutics, Inc.,
Mid Gulf Investments,
Imed Consultancy Ltd,
Ecti Ain-Rhône - Association De Bénévolat Senior Compétences,
Pharmozyme Inc,
Acorn Regulatory Consultancy Services Limited.
Regulatory Pathfinders, Llc's categories are Biotechnology Research
Regulatory Pathfinders, Llc's founding year is 2015
