• Ethics Committees
• Phase I Clinical Center
• Clinical Investigators & Research Sites
• Central Pathology Labs
• Bioavailability and Pharmacokinetics Research Centers
• Animal Pharmacology Labs
• Toxicology Labs
• Phytochemicals Research Labs
• Dermo-Cosmetology Centers

All human studies are reviewed and approved by an Institutional or Independent Ethics Committee (IEC) comprising of Clinical Pharmacologist, Consulting Physicians, Social Workers, Educationist, Legal expert & individuals of known standings, which protects rights, well-being and confidentiality of volunteers during the conduct of Study. IECs at most of our Research Sites are now following well-defined SOPs and have prompt and efficient processing of applications.

Institutional Ethics Committee

Ethics Committee for Research on Human Subjects (Established 1986) Seth G. S. Medical College and K. E. M. Hospital, Parel, Mumbai-400012.

Staff & Research Society (Established 1967) Lokmanya Tilak Municipal Medical College & General Hospital Sion, Mumbai-400022.

Independent Review Board

Bhavan’s Intersystem Biomedical Ethics Committee (ISBEC) Bhavan’s Swami Prakashnanda Ayurveda Research Centre, Juhu, Mumbai- 400049.

One of the largest hospitals in India with adequate facilities for the conduct of Phase I Studies including Pharmacology Unit & Intensive Care Unit equipped with ECG Units, Crash Carts equipped with defibrillators, Ambu Bags, Emergency Medications, -25C and -70C Chest freezers, Validated Computerized Temperature Monitoring System and Pharmacy Unit equipped with laminar Air flow and Humidity Chamber, Bioanalytical Unit equipped with LC-MS/MS, HPLC, NMR, etc. The team members include Medical or Scientific director, Principal Investigator, QA and QC manager, Technical manager, monitor, Phlebotomist, IT Support, HIV Counselor, Dietician, etc.

The Clinical Investigators are trained to carry out trials that comply with GCP. They ensure

Our Research Sites include Hospitals/Private Nursing Homes/Polyclinics equipped with adequate facilities and competent staff who understand the importance of adequate handling of Investigational Product, confidential data, etc.

Accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL) & College Of American Pathologists (CAP).

Services are provided through full automation, regular calibration and controls, standardized reagents and authorization by qualified pathologists. A cross-checking mechanism for result checking (while feeding, reporting, signing) is done to ensure total quality.

To ensure customer satisfaction, Quality Control measures are taken at each step involving Sample Handling and Labeling, Sample Collection, Sample Transport, Sample Preparation and Storage, Sample analysis, Report Generation and Electronic Data Transfer for Data Management and Reports dispatch. We ensure maintenance of a cold chain by using specialized courier companies to handle the temperature- and time-critical biological samples.

Our Bioavailability and Pharmacokinetic Research Center is a center with experience of more than two decades, which is approved by Drugs Controller General, India and recognized as Scientific and Industrial Research Organization by Government of India. It is state of the art facility, with ever expanding infrastructure.

A team of qualified professionals including Principal Investigator and Co-Investigators by having experience as Physician and Pharmacologist and by means by adequate facilities are capable of providing quality services in the field of applied research for drug as well natural products industry.

Areas of expertise include CNS, Endocrine, Nociceptive, Inflammation, Respiratory, Reproductive, Dermal, Immunopharmacology and other classical pharmacological areas.

Specialized labs to conduct in vitro studies by using cell lines like cancer studies, in vitro anti-diabetic study using pancreatic islets, etc.

All our trials are reviewed and approved by an Institutional Animal Ethics Committee comprising of Pharmacologist, Social Workers, Educationist, Legal expert & individual of known standings, which protects rights and well being and animals during the conduct of Study. The animal house is accredited by the Committee for Prevention of Cruelty in Scientific Experiments on Animals (CPCSEA), India. All the procedures of animal handling and maintenance are as per CPCSEA guidelines.

Our Toxicology group comprises of State-of-the-art laboratories with most modern, sophisticated equipments, managed by a team of well qualified, trained and dedicated professionals including over 60 scientists with over 13 years of experience in conducting studies conforming to GLP standards and practices.

The R&D centers with research facilities, and large floor area adopts a multidisciplinary approach to the study of natural products.

More than 50 scientists drive the R&D center with a true sense of scientific temper from different disciplines. It is recognized by the Department of Scientific and Industrial Research, Government of India and also holds accreditation from Indian Systems of Medicine & Homeopathy (ISM&H), Ministry of Health and Family Welfare, Government of India.

The Quality control laboratory is in the process of obtaining several other accreditations like National Accreditation Board for Testing and Calibration Laboratories (NABL) based on ISO 14874: 2000 and ISO/IEC 17025: 1999 standards, and approval from Department of Indian Systems of Medicine & Homeopathy, Government of India for testing of medicinal plants and plant products.

Areas of Competence:

A State-of-the art Cosmetology Research and Testing Laboratory recognized by Department of Science & Technology, Government of India and is involved in research areas relating to medicinal, aromatic, cosmetic and environmental biotechnology.

An independent team composed of dermatologists, pharmacists and scientific researchers who have worked in partnership with top hospital dermatology services for a number of years.

The flexibility of the team ensures a suitable response tailored to customer expectations. Thus, we can offer a wide range of services from phase I to IV clinical trials, cosmetic testing to specific tests for medical devices.

© 2006 Vedic Lifesciences