Independent assessment
Not affiliated with a particular BE centre, enabling objective scientific, technical and regulatory recommendations.
Independent bioequivalence consulting
Independent expertise for reliable bioequivalence studies.
CRO qualification, clinical and bioanalytical monitoring, data integrity review and regulatory compliance support for pharmaceutical companies.
Study quality
Data integrity
Regulatory confidence
100+BE studies audited & monitored
20+BE data reviews
2016Established
100+
BE studies audited and monitored
20+
Comprehensive BE data reviews completed
Since 2016
Independent consulting
International
CRO qualification experience
Our services
Specialist support across the BE study lifecycle.
From CRO selection and study planning to monitoring, data review and regulatory submission support.
1 of 7
01CRO qualification & pre-study audits
Independent assessments to determine whether a CRO has the facilities, personnel, technical capabilities and quality systems required for the proposed study.
- Clinical and bioanalytical facility assessment
- Quality management system and SOP review
- Personnel qualification and training assessment
- Data management and data integrity system assessment
- Remote and on-site CRO qualification audits
02Clinical BE study monitoring
Monitoring of study conduct against approved protocols, applicable requirements and Good Clinical Practice principles.
03Bioanalytical study monitoring
Independent verification that sample analysis follows validated methods and that data are reliable, traceable and properly documented.
04BE data integrity & report review
Independent review to identify potential errors, inconsistencies and compliance gaps before regulatory submission.
05End-to-end BE study compliance management
Project-specific oversight throughout the study lifecycle to support consistent study quality and compliance.
06Regulatory query & inspection support
Support in evaluating regulatory observations and developing appropriate technical responses.
07BE centre establishment & professional training
Support for organisations establishing or improving clinical and bioanalytical facilities for bioequivalence research.
Why choose Biointegrity?
Independent assessment. Practical experience. Regulatory focus.
We help pharmaceutical companies identify compliance risks, strengthen study oversight and ensure that clinical and bioanalytical data are appropriately documented, traceable and suitable for regulatory evaluation.
Practical experience
Experience across clinical research, bioanalytical operations, quality assurance and regulatory compliance.
Clear technical reporting
Practical recommendations, timely issue identification and technically focused reporting.
Experience
Built around real BE study execution and review.
Biointegrity Consulting was established in 2016 in Bengaluru, India. The team brings experience across clinical research, bioanalytical operations, quality assurance and regulatory compliance.
100+Studies audited & monitored
20+Comprehensive data reviews
India + InternationalCRO qualification assessments
Multiple dosage formsSolid oral, liquid oral and inhalation products
Regulatory markets
Experience supporting studies intended for major regulatory authorities.
The applicable regulatory requirements are considered for each assignment.
United StatesFDA
European UnionEMA
United KingdomMHRA
BrazilANVISA
MalaysiaNPRA
SP
Sabyasachi Patri
Founder, Biointegrity Consulting
Leadership experience
Hands-on experience across bioequivalence research and compliance.
Sabyasachi Patri has extensive experience in bioequivalence research, bioanalytical operations and compliance management, including previous industry experience at Ranbaxy Research Laboratories and Sun Pharmaceuticals.
Contact us
Discuss your bioequivalence study and compliance requirements.
We work with pharmaceutical companies in India and internationally, providing flexible consulting services tailored to the scope and complexity of each assignment.