Bioavailability & Bioequivalence Studies
100+ Marketing Authorizations Obtained Through our Bioavailability & Bioequivalence Study Services
With over 90% of the prescriptions in the US market being fulfilled by generics companies, the competition in this space is growing exponentially. This makes it imperative for generics companies to be first-to-market, while adhering to stringent regulatory requirements, ensuring high quality outputs, and maintaining a cost advantage.
Critical Drivers for Generics
Speed to Market
High Quality Output
Navitas Life Sciences Delivers Outcomes Through High Quality BA / BE Studies and Beyond
Navitas Life Sciences provides clients with End-to-End Bioavailability & Bioequivalence services for generics companies. Our services include study design, conduct, bioanalysis, data standardization and analysis, dossier preparation and regulatory submissions, and pharmacovigilance.
With a highly qualified and experienced team in place, Navitas can deliver even complicated studies with high quality outputs. We have experience in a wide variety of studies including multiple doses, dosage form, dose escalation, single and double blind, PK/PD end point studies, Glucose clamp studies, proof of concept and exploratory, repeat “first in man”, nutritional, special population, drug interaction, and more.
All of our infrastructure and systems are setup to guarantee high-quality outputs and compliance for generics companies. Our state-of-art facilities are approved by DCGI, NPRA Malaysia and self identified with USFDA. The facilities, systems and processes have been inspected successfully by the USFDA, WHO, ANSM, AGES, Thai FDA, NPRA & DCGI. Additionally many studies performed at our facilities are submitted, evaluated and accepted across the globe (eg: Health Canada, EU member states, Indonesia and Australia.
We are ISO 9001-2015, ISO 27001-2013 certified for Quality Management System and Information Security Management System. The Clinical laboratories performing pathology testing are accredited by NABL (National Accreditation Board for Laboratories; ISO15189-2012) and CAP (College of American Pathologists).
Thus, Navitas Life Sciences provides comprehensive and personalized services from a highly skilled team, backed by high-quality infrastructure and systems, enabling high-quality outcomes for Generics companies.
We Drive Successful Outcomes for Generics
Accelerated Submission Timelines
High Quality Outputs