Independent Consultancy · Bioequivalence, Bioanalysis & Regulatory Strategy
Pay a fair price. Choose the right CRO. Design the right study.
BioEquiv provides independent consulting on bioequivalence and bioanalysis trial design, CRO selection, and study cost review for pharmaceutical sponsors.
Over 30 years in pharmaceutical R&D, with more than 3,000 bioequivalence, bioavailability, and pharmacokinetic studies quoted and managed for sponsors worldwide — submitted to the EMA, US FDA, and WHO. Consultations available in Arabic, English, and Spanish.
3,000+
BE / BA / PK studies quoted and managed
30+
Years in pharmaceutical R&D
4
Editions of the MENA Regulatory Conference
3
Languages: Arabic, English, Spanish
Studies submitted to the EMA, US FDA, and WHO. Co-organizers of the MENA Regulatory Conference on Bioequivalence, in partnership with AAPS, EUFEPS, FIP, and TUFTAD. We work only for sponsors — never for the CROs and sites we assess.
What we do
Three services, built around the decisions that determine a program’s cost and credibility
What the study should cost, who should run it, and how it should be designed. We advise on all three from the sponsor’s side of the table.
01
Study Budgeting & Quote Review
We review CRO quotes against realistic market pricing, so you know whether you are being quoted fairly and where there is room to negotiate. We also build a defensible budget before you approach a single CRO — per-task benchmarks, typical ranges by study phase, and the line items most often inflated.
Deliverable: a market-benchmarked study budget and an independent quote review.
02
CRO & Site Selection
We run due diligence on candidate bioequivalence and bioanalysis CROs and clinical sites, then stay on through the study — milestone oversight, quality and compliance monitoring, and risk assessment with mitigation plans. Candidates are sourced from three decades of direct working relationships across the region.
Deliverable: a comparative CRO and site scorecard with a risk-rated recommendation.
03
Study Design & Regulatory Strategy
We advise on bioequivalence, bioavailability, and pharmacokinetic study design, protocol strategy, and the regulatory pathway — grounded in 3,000+ studies submitted to the EMA, US FDA, and WHO, and in what those reviewers actually accept.
Deliverable: a study design and regulatory strategy memo for your target markets.
Ways to work with us: independent quote review (one-off) · project oversight (retained) · advisory board membership · workshops and seminars · thought leadership content
Designing a study, selecting a CRO, or wondering whether your quote is fair?
We have quoted and managed more than 3,000 BE/BA/PK studies for sponsors worldwide. Tell us what you are working on.