We support pharmaceutical, biotech and medical device companies with clinical trials, bioequivalence studies, bioanalytical services, monitoring and product characterization.
A dedicated bioequivalence centre providing clinical and bioanalytical services to pharmaceutical, medical and biotechnology companies internationally. Our clinical pharmacology experts guide your product through the clinical phase and bring the best results to the table for your decision.
A small-molecule and biologics-focused analytical laboratory operating in a state-of-the-art 6,000 sq ft facility, from early discovery and preclinical bioanalysis to clinical and post-marketing studies.
Taking new therapies from research to market takes a CRO that works hand in hand with you. We support you at every point, from product research and development to market authorization.
Third-party monitoring is a fool-proof way to catch errors that could affect the credibility of a study. Our independent experts make sure that not just the study, but the site too, is audit ready.
Our regulatory affairs team is made up of former drug inspectors and senior officers of regulatory agencies. Drawing on years of experience, they guide our clients through the regulatory aspects of their projects and through inspections.
Our medical writing team brings together scientists from many fields of research. Working closely with subject-matter experts, consultants and our regulatory team, they deliver reports and documents of the highest quality. When the documents do the talking, you don't have to.
A not-for-profit spin-off of BioRadius that empowers and nourishes young talent in clinical research, with custom-tailored hands-on programs and workshops for students and doctors.
The science
A generic must deliver the same drug exposure as the innovator product. We measure it directly in the blood.
How we work
Diligent planning and detailed foresight: we review your product, reference and target markets, then recommend a scientifically sound study design.
Our medical writers and regulatory team prepare the protocol and secure ethics and regulatory approvals.
Volunteer or patient dosing, sampling and validated bioanalysis, following all applicable guidelines.
Pharmacokinetic and statistical analysis, a submission-ready report, and support through regulatory audits and queries.
Let's bring it to the market together. Tell us about your product and timelines, and we'll come back with a plan and a quote.