Pharmaceutical Gap Analysis is the most effective route for designing and finalizing a drug development program. A new drug development process can be a costly affair. This cost may further be increased by inaptly designed or needless clinical trials. With a higher risk of failure, greater uncertainty and more expense, there is a need for an optimized strategy to better utilize the resources, time and money to get the drug to the market. The first step in performing a strategy called Gap Analysis.

What is a Gap Analysis Development Strategy?

A Gap Analysis identifies any missing elements in the data providing specific action items to fill those gaps before submitting the application to the regulatory agency.  A gap analysis development strategy ensures that all relevant fields are covered, gaps are appropriately addressed, all of the elements needed for informative actionable product labeling are clear to enhance decision-making during development.


Concept 2 Clinic Expert Gap Analysis Questionnaire:

With the help of our experts, we have developed an extensive list of questions that regulatory agency reviewers seek. Several example questions are provided below:

  • What developmental steps have the applicants identified as being necessary to advance the technology toward commercialization? 
  • Is the research plan well designed and feasible?  Can it be improved?
  • Is there a reasonable expectation that the work will strengthen the IP position or generate new IP? 
  • Is there a reasonable expectation that the work will provide unambiguous information relevant to the assessment of the commercial potential of the technology?
  • What is the effect of food on the bioavailability of the drug from the to-be marketed dosage form?

By addressing all gaps before submission, you will save your program unnecessary resource, time and money.

Concept 2 Clinic Clinical Pharmacology Development Program

Concept 2 Clinic’s experts evaluate different questions that the agency will ask at the time of a New Drug Application (NDA) submission. Thus, we can assist in the evaluation of your drug program and tackle any potential gaps prior to you meeting with the regulators at the end of Phase 1, Phase 2 or Pre-NDA. We will recognize the potential Research and Development (R&D) or regulatory challenges related to the molecule, therapeutic area, and competitive landscape. We also offer readiness support and help guide interactions with regulatory agencies for research programs and submissions. We assist in creating a clinical pharmacology development program in line with regulatory filing strategy. We help in aligning pre-clinical findings with planned clinical programs. Lastly, we help in Minimizing post-marketing requirements.

At Concept 2 Clinic, we understand that time, money and resources are always constrained in drug development. Book a Free Consultation with us today to learn how gap analysis can increase your drug program’s likelihood of regulatory and commercial success.