Bioequivalence Study Services

At Pragya Dossier-DMF Services, we specialize in providing comprehensive Bioequivalence (BE) Study services tailored to meet the regulatory requirements of various countries. Our expert team ensures that your products meet the necessary bioequivalence criteria, facilitating their approval in both domestic and international markets.

Our Bioequivalence Study Services include:

• Country-Specific Compliance: We conduct BE studies adhering to the specific guidelines and regulations of the target market, ensuring a smooth approval process.

• Thorough Study Design: Our studies are meticulously designed to compare the bioavailability of your product with that of a reference product, ensuring accuracy and reliability in results.

• Data Analysis & Reporting: We provide detailed data analysis and reporting, following the stringent requirements of regulatory authorities, to support your submission process.

Partner with Pragya Dossier-DMF Services for reliable, efficient, and compliant Bioequivalence Study services that enhance your product's success in the global market.

PDDS provides effective writing / reviewing the Bioequivalence Study as per WHO / Country specific guideline. Post sale, We provide cost-free support till product registration..

BIOEQUIVALENCE STUDY:
We do:
- BE Protocol Design and prepare BE report
- Biostatics work and review of BE studies
- Bioanalytical Protocol and report - Preparation and review
- Biowaiver report - Preparation and review