With patents expiring on all of the top 30 biological drugs before 2025, this is an exciting time for Biosimilar launches. However, this opportunity also calls for advanced technical and regulatory expertise for study success. With intense competition for sites and patients, sponsors must equip themselves to emerge on top:

  • Healthy volunteer experience is required to monitor potential severe adverse responses to biosimilar drug
  • Lean phase 3 protocol design is necessary to gain market approval as efficiently as possible
  • Cost efficiency is essential to capture market share
  • Regulatory requirements of study quality remains as high as innovator research

Navitas Life Sciences Is Here to Help

With a global presence, our experience across innovator pharma and biologic Phase III studies, and PK/PD enables us to partner with you to meet accelerated submission timelines while optimizing trial casts and regulatory risk of non-compliance.

  • 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 possible 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
  • Optimized and efficient trial conduct and analysis platform, OneClinical

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