Are you looking for a project leader for your Drug repositioning / Repurposing or Proof-Of-Concept Studies?

If you have a drug that has been previously approved by the FDA and are looking for drug repositioning /repurposing or proof-of-concept trial studies for existing or new chemical entity, we could manage the entire project in a time-efficient manner. Furthermore, in conjunction with our USA-India Connect services. , we could deliver high quality, cost-effective clinical and manufacturing solutions. Thus, saving millions of dollars by reducing time, development cost, and capital expenses to a virtual/semi-virtual biotechnology companies.

Our technical team will work with you to prepare a comprehensive drug development plan including gap analysis and compilation of the pre- IND package with proposed bridging preclinical, and clinical studies for your pre-IND meeting with the FDA. This would assure that your clinical trial program is on target, using the relevant bridging & pivotal clinical trial studies. Our experienced team of advisors & consultants have been dealing with the FDA for decades, and will be highly effective in managing the regulatory risk.

• Published literature search on Safety and Efficacy of the previously approved drug for drug repurposing
• Pre-IND Package preparation, including Gap Analysis, proposed bridging preclinical, clinical studies for Pre-IND meeting with the FDA
• Clinical Protocol, Investigator's Brochure Writing
• CRO /CMO due-diligence, selection and management
• Clinical Proof-of-Concept (POC) and Pivotal bridging clinical Studies Project Management, including milestone deliverables and timeline
• IND, and 505(b)(2) NDA preparation & submission