Based on GCP and GLP compliance BA/BE studies are conducted at Navitas. Marketing Authorization has been awarded by the US FDA, Health Canada, EMA, MHRA, TGA, MCC, Thai FDA, DCGI and WHO
We offer end-to-end services including: regulatory consulting, IP import, protocol design, ethics committee submissions, screening, clinical study execution, bio analytical testing, pharmacokinetic, statistical analysis and report writing. We have proven expertise in clinical study management, method development and validation, data management with Oracle Clinical, PK analysis using Phoenix WinNonlin, statistical analysis using SAS and CDISC compliant reports in eCTD formats.
Wide Range of Studies
BA/BE studies for generic molecules and intensive PK/PD studies for NCEs are conducted in normal healthy volunteers and patients. We have access to Caucasian and Mongoloid subjects. Studies can be at single center or multi-center. We have also conducted studies for regulatory pathways like 505b(2) and Clinical Endpoint BE. Variety of dosage forms including: tablets, capsules, suspension, ODT, sub-lingual, topical emulsion, spray, inhaled vapor, transdermal patches, injectables, etc. Study designs include: first-in-man, dose finding, PoC, drug interaction, food effect, bridging, reference scaled average BE design, two stage adaptive EMA design etc.
We can analyze in multiple matrices including: blood, plasma, urine, skin and bone. We have experience in highly variable molecules, hormonal products and analyzing trace elements at parts per trillion. We serve global companies in the Pharma, Biotech and Nutrition industry from US, Canada, Europe and Asia.
Clinical Pharmacology Centers
Our clinics are located at multi-specialty teaching hospital campus ensuring the highest standards of safety. The clinics are audited by DCGI and international regulators and are self-identified with US FDA as per GDUFA. Clinic design allows mixed gender studies as well as light sensitive molecules.
Equipped with an advanced ICU to handle emergencies, Navitas Life Sciences clinics are centrally air-conditioned, access-controlled with dedicated areas for screening, counselling, housing, phlebotomy, pharmacy and recreation & dining rooms. The ICU beds are equipped with defibrillators, ventilators, cardiac monitors, oxygen supply, crash cart and required emergency medicine.
Our clinics are designed to meet highest standards of volunteer safety and comply with DCGI specifications. We have access to additional clinics in France, Jordan, China, Thailand and India to meet client needs for marketing authorizations in these areas.
Institutional Ethics Committee
Prior to conduct, all studies are approved by Manipal University Ethics Committee which is registered with the office of Human Research Protection, US Dept. of Health & Human Services and DCGI. It has the distinction of being ‘first in country’ to be accredited by Association for Accreditation of Human Research Protection Program (AAHRPP Inc.).
We have an in-house GLP compliant analytical lab with a bank of LCMS/MS and additional instruments such as Flow Cytometry, ICP-MS, and automated blood coagulation analyzers. Our analytical experts reputed for quick turnaround have developed hundreds of methods (including many challenging methods) in different matrices. Additionally, our PK expert’s opinion is often sought by formulators to make improvements to their difficult molecules.
Study Team and Volunteer Access
Our study teams have many years’ experience conducting studies and consists of both MDs in the clinic and Pharmacy PhDs in the lab.
We have a database of over 15,000+ volunteers including post-menopausal women and geriatric volunteers. Located in super-specialty hospitals, we have access to oncology, psychiatry, dermatology, diabetics and renal impaired patients. ISO-certified Clinical Testing Laboratories accredited by the College of American Pathologists and NABL ensure volunteer inclusion with protocol compliance. Our lab is located in the same facility as the clinic ensuring quick turnaround.
Regulatory Compliance and Quality Assurance
We have an independent QA department ensuring study compliance to current guidelines with SOP’s, training and audits. Periodic certification to ISO 9001, ISO 27001, ISO 15189, 21 CFR part 11 provides further assurance.
Based on our study data regulatory authorities in US, European Union, UK, South Africa, Latin America, India and SEA have granted marketing approvals for multiple molecules.
Our reputation excellent quality, on time delivery, at competitive cost, with personalized service has earned us exceptional customer loyalty.
Be Ahead of Guidelines with Navitas®