Proven First-to-File Success

Competition among generic pharmaceutical companies to gain market advantage is increasing day by day. The sooner they bring the drug to market, the larger the market capture. USFDA also encourages this approach to bring down the overall expenditure on health care cost. The agency rewards the company making first to file ANDA applications with 180 days exclusivity. However, Bioequivalence studies are complex and involve Planning, resourcing, timeline management, technical capabilities, coordination and decision opportunities, which make improving performance a multidimensional challenge.

If a study is not designed properly, execution breaks down, leading to loss of opportunities for the client. We at Veeda understand this and have designed special task force to carry out such time sensitive and intensive planning & coordination demanding studies.

1
We at Veeda take pride to state that we have the technical capabilities, required resources and proven track record in helping our business partners to make their first to file programs successful. We are capable of getting required regulatory permission well ahead of the study execution, shortest possible time to enroll required number of subjects and highest number of LCMS/MS machines as compared to any other Indian CRO to help you with your file to file ANDA applications.

Some of the highlights of our capabilities and achievement are as listed below:

  • Excellent regulatory network with proven track record to get approvals in time
  • Good database of healthy subjects and an excellent enrollment team capable of recruiting over 250+ subjects with a merely 24 hour advance notice
  • Team of over 750+ personnel to meet the timeline expectations of the project
  • Dedicated task force for clinical execution, data review, Bioanalysis, PK statistical analysis and report writing to handle first to file projects
  • Highest number of LCMS/MS machines as compared to any other Indian CRO