Pearl Pathways
Pearl Pathways is a comprehensive life sciences professional services company dedicated to accelerating the development of therapeutics, devices, and diagnostics. They partner with clinical, regulatory, quality, and leadership teams to streamline product development, navigate complex regulatory landscapes, and bring life-saving products to market faster. Their services span regulatory strategy, clinical research, quality compliance, and independent review board services, supporting clients from startups to multinational corporations. With a focus on innovation, compliance, and efficiency, Pearl Pathways aims to be a trusted advisor and partner in the life sciences industry.
Industries
Nr. of Employees
small (1-50)
Pearl Pathways
Near downtown Indianapolis in the August K. Sommer House, a historic building with a rich German community history.
Services
Regulatory strategy, preparation of global submissions (IND/NDA/BLA/MAA/ANDA/CTA), eCTD publishing and communications with health authorities.
Implementation and management of GxP quality systems, audits, validation support, remediation, and supplier/CMO oversight.
Full-service clinical research organization capabilities including study design, feasibility, site start-up, monitoring, data management, biostatistics, and medical writing for Phase I–IV studies.
Central IRB review, expedited and full board reviews, exemption determinations and AAHRPP-accredited human subject protection services.
IVD and companion diagnostic development support including validation, regulatory strategy for FDA and EU IVDR, and commercialization planning.
Functional service provision and partnerships with CROs, CMOs, laboratories and sites to deliver outsourced capabilities and augment client capacity.
Regulatory strategy, preparation of global submissions (IND/NDA/BLA/MAA/ANDA/CTA), eCTD publishing and communications with health authorities.
Implementation and management of GxP quality systems, audits, validation support, remediation, and supplier/CMO oversight.
Full-service clinical research organization capabilities including study design, feasibility, site start-up, monitoring, data management, biostatistics, and medical writing for Phase I–IV studies.
Central IRB review, expedited and full board reviews, exemption determinations and AAHRPP-accredited human subject protection services.
IVD and companion diagnostic development support including validation, regulatory strategy for FDA and EU IVDR, and commercialization planning.
Functional service provision and partnerships with CROs, CMOs, laboratories and sites to deliver outsourced capabilities and augment client capacity.
Expertise Areas
- Clinical trial management
- Regulatory strategy and submissions
- Quality systems and GxP compliance
- CMC development and supplier oversight
Key Technologies
- eCTD and electronic regulatory publishing
- Electronic Data Capture (EDC)
- Interactive Web Response Systems (IWRS) / randomization
- Biostatistical analysis and programming
News & Updates
The site feasibility process has been a source of angst among Sponsors/CROs and sites for years....
Last February, Senate leaders addressed FDA Commissioner Robert Califf, M.D. asking the Agency to...
On April 29, 2024, FDA introduced a significant regulatory shift affecting the landscape of...
The site feasibility process has been a source of angst among Sponsors/CROs and sites for years....
Last February, Senate leaders addressed FDA Commissioner Robert Califf, M.D. asking the Agency to...
On April 29, 2024, FDA introduced a significant regulatory shift affecting the landscape of...