BioPharma Services Inc.

Overview

BioPharma Services is a full-service contract research organization (CRO) founded by two surgeons dedicated to advancing medical science. The company specializes in early-stage clinical drug development, with particular expertise in Phase 1 and Phase 2a clinical trials.

Core Services

Clinical Trial Services:

• Phase 1 and Phase 2a clinical trials across diverse therapeutic areas
• Bioequivalence (BE) and Bioavailability (BA) studies for generic and hybrid drug filings and 505(b)(2) New Drug Applications
• Human Abuse Potential (HAP) studies with extensive experience in opioids, narcotics, and cannabinoid products
• Abuse Deterrent Formulation assessments
• Psychedelic clinical trials (psilocybin, psilocin, high and microdosing studies)
• PET clinical trials and molecular imaging studies
• First-in-human (FIH) and single ascending dose (SAD) studies
• Multiple ascending dose (MAD) studies
• Food effect studies
• Proof of concept studies

Support Services:

• Bioanalysis and bioanalytical testing with LC/MS/MS platforms
• Data management and CDISC standards compliance
• Medical writing
• Clinical biostatistics and biometrics
• Pharmacokinetics (PK) and pharmacodynamics (PD) analysis
• Scientific affairs consultation
• Subject recruitment from extensive volunteer database including special populations
• Trial protocol development

Facilities & Infrastructure

• State-of-the-art clinical research facility in Toronto, Ontario with 150–200 bed capacity
• In-house bioanalytical laboratory equipped with latest LC/MS/MS platforms
• Conducted approximately 2,500 bioequivalence and Phase I clinical trials
• Experience across therapeutic areas including neurology, cardiology, immunotherapies, and infectious diseases

Regulatory & Quality

• GCP and GLP compliant operations
• GLP certified by the Standards Council of Canada (SCC)
• History of successful regulatory inspections by US FDA, UK MHRA, ANSM, DKMA, ANVISA, Health Canada, and WHO
• Adherence to ICH principles
• Proven expedited timelines including First-to-File services for US FDA submissions