Industry dynamics are placing increasing demands on generics R&D organizations. The competition for first-to-market advantage is growing rapidly, with an increasing regulatory pressure on prices. With over 90% prescriptions in the US being fulfilled by generic drugs, the BA/BE market is an essential one in Life Sciences company. In bringing a generic drug to market, sponsors need to be on speed with many key aspects:

  • Speed to market is essential to be the first company awarded 6 months exclusive market access
  • Bioanalytical capability is essential to determine bioequivalence
  • Cost efficiency is essential to capture market share
  • Regulatory requirements of study quality remain as high as innovator research

Navitas Life Sciences Is Here to Help

Navitas has successfully conducted studies for submissions in 6 continents, with over 100 marketing authorization approvals Our services are helmed by a highly skilled team of specialists which include qualified medical practitioners and PhDs, delivering:

  • Accelerated onboarding of healthy volunteers from our 20,000+ database, including geriatric age range
  • Access to speciality hospitals with patients in oncology, psychiatry, dermatology, diabetes and renal impaired patients
  • Rapid set-up with tailored multi-analyte methods ready in 4-5 weeks. Library of pre-validated assays in 10+ matrices including skin and bone
  • 100% adherence to regulatory guidelines with an independent QA department, SOP’s, training and audits
  • ISO 9001 certified Quality Management System
  • FDA 21 CFR Part 11 compliant computer systems for sample and data analyses
  • Bioanalytical labs at the forefront of technology and analytical capability, CAP and ISO-15189 accredited
  • Computer system validation for data management processes
  • Fingerprint-based cross-volunteer participation software to detect overlaps with parallel studies
  • Cost-effective location with no competing facilities in the region, leading to exclusive subject access in catchment area

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