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Generic Drug Development Services

We know that generic drug development requires a strong CRO lab partner. Developing a bioequivalent demands efficient, high quality, and regulatory compliant analyses at every step. BASi delivers efficient bioanalytical method development and sample analysis as well comprehensive pharmaceutical analysis including stability program support, method validation, and final product release testing. Our scientists will be there supporting you from early phase R&D work to ANDA submission and post-market with sample analysis and stability testing.

Services

Early Phase R&D

Pharmaceutical Analysis Services

Benefits

  • Quality and cost effective results
  • Fast turnaround of data
  • Efficient and nimble processes to meet your timelines
  • Scientist-to-scientist timely communication
  • Strong client partnerships
  • Exemplary regulatory record
  • Efficient GMP/GLP Services
  • Expert technical staff
  • Multiple sites in US and Europe

FDA Issues Guidelines on Developing Biosimilar Products