Bioequivalance Studies

Our Services

Ensuring Compliance and
Reliability

Our Services

What we offer

We advise for the successful conduct of BA/BE Studies/Clinical Trials

- CRO Selection – Selection of appropriate CRO
- Technical Inputs – Scientific inputs for Protocol
- Quality Compliance – Due Diligence of CRO and its procedures
- Monitoring – Monitoring of Clinical/Bioanalytical Phases
- Review – Critical review of report and study data
- Trainings – GCP/GLP Trainings and workshops through our experienced team and guest speakers

Area of Services - Scope

- Compliance with GCP/GLP norms as stated in the SOPs and Policy documents
- National and international approvals and accreditations
- Ability to manage adverse events
- Previous experience with the molecule of interest
- Quality and capacity of bioanalytical equipment
- Does the validated method have requisite sensitivity and specificity demanded by the protocol
- Understanding of the principles of pharmacokinetics as applicable for bioequivalence

- Audit of bioanalytical laboratory systems to assess the correctness of assay results through systems and procedures audit, in-house laid down procedures with respect to the regulatory guidelines for method validation, study analysis and data reporting
- Audit of Instruments and IT procedures, computer systems validation, calibration procedures, Reporting Procedures and laboratory Information management system (LIMS) or any other laid down procedure
- Auditing all Documentation procedures, Analytical report, MD/MV Report, data recording, chromatographic review etc.
- In-process Monitoring of BA Activity
- BA in-process monitoring is done when study analysis is in progress to check the SOP compliance. Subjects are chosen randomly or Repeat Analysis/ incurred Sample Analysis is audited

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