Bioequivalence
Studies
End-to-end CRO services for bioequivalence studies from clinical phases I to IV, offering complete support from IMPD review to final reporting.
One-stop Solution for GLP-certified Bioequivalence Studies
From study design to regulatory submission, BrownBiology Laboratory has extensive experience managing comprehensive GLP bioequivalence studies. We offer an end-to-end solution, working in alliance with reputed European clinical centers to conduct the in vivo phase following EMA, FDA, and ANVISA guidelines.
Our laboratories are equipped with an extensive pool of LC-MS instruments and follow the ICH M10 Bioanalytical Method Validation guideline. We offer narrow timelines and competitive sample prices, with method development and validation provided reliably.
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Our One-Stop Shop
BrownBiology Laboratory is fully coordinated with our alliance partners offering high-quality standards, narrow timelines, and competitive prices across these key areas:
Bioequivalence Studies Management
- Study design and protocol writing
- Submission to Ethics Committee and Health Authorities
- Insurance contracting
- Clinical center management and monitoring
- Bioequivalence studies execution
Bioequivalence Studies Reporting
- Phoenix WinNonlin庐 data analysis
- Pharmacokinetic report
- Final clinical report
- Specific reports to Authorities requests
Bioanalysis for Bioequivalence Studies
- Method validation following ICH M10 guideline
- Long term stability
- LC-MS/MS and HRMS for small molecules
- ICP-MS for metal/organometallic analysis
- ELISA, ECLA, and RIA for small peptides
Support Activities to Bioequivalence
- Procurement of reference medication
- IMPD review & Comparative dissolution profiles
- Importation of reference and test products
- Batch testing and batch release
- Central lab testing, Pharmacovigilance & Sample storage
FDA Compliant Regulatory Excellence
BrownBiology Laboratory's bioanalytical facility and our Partnered Clinical Centers operate in strict compliance with FDA guidelines to conduct bioequivalence studies intended for submission to US authorities. We have established strategic partnerships to offer a complete one-stop-shop solution, providing our clients with a reliable, cost-efficient, and streamlined regulatory pathway to market generic products in the United States.
Bioanalytical Expertise
Decades of experience developing and validating robust bioanalytical methods.
Clinical Experience
Our partners' proven track records in Phase I studies ensure the highest compliance.
End-to-End Service
From initial study design to final regulatory submission, a fully integrated workflow.
Why Choose BrownBiology?
Regulatory Excellence
FDA, EMA, and ANVISA inspected, GLP-certified, and GCP-compliant workflows.
Global Trust
Trusted partner for bioequivalence studies by leading generic manufacturers worldwide.
Extensive Expertise
Proven experience of decades developing and validating generic bioanalytical methods.
State-of-the-Art
Large pool of equipment for small molecule bioanalysis and instrumental techniques.
Ready to accelerate your drug development?
Let's tailor the perfect bioequivalence solution for you. We offer an extensive list of validated methods.