Raptim Research

Raptim Research is a contract research organization offering regulatory-compliant services across clinical trials, BA/BE, and bioanalytical studies for Biopharma, medical device, and consumer healthcare clients.

Services

• BA/BE: Healthy subject bioequivalence and bioavailability studies, pharmacokinetics (PK), pharmacodynamics (PD), and patient-based PK/PD and clinical endpoint (CE) studies.
• In-vitro studies: In-vitro release rate testing (IVRT) and in-vitro permeability testing (IVPT), in-vitro binding studies, and BCS biowaiver studies.
• Special studies: In vivo tape stripping, in vivo dermal microdialysis, skin blanching, skin irritation and sensitization testing, and glucose clamp studies.
• Clinical trials: Early phase clinical trials, patient-based PK/PD/CE studies, Phase II-III trials, and Phase IV and post-marketing studies.
• Bioanalytical lab: Bioanalytical method development and validation, with over 600 validated methods cited on the site.

Regulatory and infrastructure

• Cleared 32+ USFDA inspections along with other audits by major regulatory authorities, according to the site.
• Milestones listed include a UK MHRA inspection, a WHO inspection, and GCC approval.
• Clinical capacity is stated as 390 beds in total, including a 12-bed Phase I facility in Mumbai and 38 beds approved for BA/BE studies.
• Quality assurance and quality control work covers IVRT/IVPT, NG tube, inhalers, and BCS biowaivers.