Bioequivalence (BE) & Bioavailability (BA) Studies
With over 2000+ studies conducted between two clinical sites in Toronto, Canada and St. Louis, USA, BioPharma has built a brand of excellence in the conduct of Bioequivalence (BE) and bioavailability (BA) studies to support both generic and hybrid drug filings and 505(b)(2) New Drug Applications.
With impeccable quality and reputable data in mind, the BioPharma team is trained and empowered to deliver its very best each and every day. This attention to detail is supported by numerous successful Regulatory Inspections from the US FDA, EMA, UK MHRA, ANVISA, and Health Canada. With our in-house scientific and regulatory expertise, proficient in all major drug markets, BioPharma can support the full study conduct from study design and protocol inception to the issuance of the final Clinical Study Report.
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State of the art facilities. World class leaders. Innovative scientific expertise
With a strong profile of studies conducted on solid oral formulations, BioPharma has also amassed scientific intelligence in the conduct of studies for:
- Solid oral dosage forms for IR, ER, MR formulations
- ODT and SL formulations
- Inhalation products
- Transdermal patches
- Long-acting depot injections
- Creams, suppositories and ointments
Our team of PK Scientists, Clinical Operation specialists and Clinical Investigators work together to ensure the competent execution of BE studies that adhere to the Good Clinical Practice (GCP) principles that govern our industry. Supported by our Quality Control processes and governed by our Quality Assurance experts, we are committed to delivering excellence in clinical research with an unwavering commitment to service and client satisfaction.