(Bioavailability / Bioequivalence Studies)
Spread over 12,500 sq.ft , we provide contract research services in areas of bioavailability and bioequivalence studies. We deliver T-TRAC i.e. Timely – Traceable, Reliable, Affordable, Consistent test results to the Pharmaceutical companies world wide.
BioSRL has systems implemented for offering the following Service Values to meet our client’s requirements:
- Rapid Recruitment of Subjects
- Time-bound Project Delivery
- Complete project package of Bioavailability/Bioequivalence Studies.
- Independent services in Clinical, Bio-analytical and Statistical analysis as per the requirements of our clients.
- Healthy volunteers
- Special patient populations:
- Post-menopausal women
- HIV positive
- Hepatic, renal impaired
- Ulcerative colitis
- Single/multiple doses
- Fasting/fed condition
- Immediate release preparations
- Complex Formulations & Alternative Delivery
- Modified Release Oral Formulations
- Fixed dose combinations
- Topicals (creams, gels, ointments)
- Nasal Sprays
- Ophthalmic Therapeutics
- Vaginal Preparations
- Suspensions, Emulsions, Powders
Bio-analytical methods development and validation using LC-MS/MS and HPLC for Evaluation and Quantification of active moiety and metabolites from biological matrix using various extraction techniques.
Our expertise in rapid methods development and validation offers timely and cost effective analysis of samples. The Bio-analytical facility is designed and equipped with world class standards and all procedures are GLP compliant.
We have designed and implemented quality system to meet the Local (ICMR) and International GCP (ICH GCP) and GLP standards and are also oriented with respect to requirements of various regulatory across the globe. QA independently monitors all the activities to ensure compliance to protocol, SOPs, GCP, GLP and other relevant laws and regulations.
All the persons are well trained in their respective areas of operations. Constant efforts are made to update their knowledge through In-house and external training programs.
Our project management team gives periodic updates to the clients on progress of each project. All communications are transparent and are through secured email, teleconference or periodic face to face meetings.