Your Partner in Evaluating, Mitigating and Reversing Compliance Risk

I wanted to take a moment to personally thank you for contributing to our facility design team by providing advice on Europe’s requirements during our planning and design phase for our facility modification. Although we did not incorporate the Europe’s standards into our design, we appreciate your responsiveness and insight to our questions concerning the European requirements for aseptic manufacturing of pharmaceutical products. We look forward to the opportunity to work with you in the future .

Ruchika, I want to personally thank you for your contribution to the vaccine adjuvant development program with our agency. Your expert comment made an ipmortant and valuable contribution towards advancement of biomedical research. Best for your future.

I am personally pleased to have reviewed and worked with this group. The expertise Ruchika brought was an essential element and valuable to the discussions. I hope this was a positive experience for you and i hope we will work together in the future.

Ruchika, Thank you for your contributions towards the three Orphan Drug Designations awarded to Children’s Hospital. Your provided valuable expertise in the research that went into the science, medicine and application or our technology as well as the production of the document that went to FDA. I think the critical point in the project was the Briefing Meeting with the FDA Office or Orphan Drug that you initiated and the resulting discussion which was essential in defining the strategy as to which clinical indications will be pursued for each drug. Your initial proposal, the overall strategy, FDA meeting execution and the resulting submission was key to our getting three Orphan Drug Designations Awarded to our institute.

Your firm provided an overall assessment of our “Quality Program”. GBR evaluated our Quality Policy, Processes, Documents and Key Personnel. The report was provided in a tight timeframe which in itself was impressive, but it was thorough and we were able to utilize the information in refining our program. Similar sentiments were shared by my colleagues in the company. In future I hope I can count on your firm for help within your expertise.

This is to acknowledge GBR’s Contribution as interim Regulatory. In the one year, you prepared 18 Regulatory submission pieces that were actionable by FDA, with no loss of time, deficiency letter or other adverse agency actions that would impact my firm. Note worthy were (1) CBE-30 for alternate suppliers, with no impact to lot release (2) Facilitate CMO in and FDA inspection of facility located in XX. Obtain FOIA and critically analyze and recommend regulatory sensitive issues during the acquisition of XX from XX by our firm. (3) Coordinate with us, XX, US-FDA and C-FDA regarding NDC code, labeling and advertising material for XX. Thank you for introducing us to XX to transition into our Regulatory Group and internalize the capability.

I would like to thank you GBR to help prepare our firm for the ISO13485 inspection by the Notified Body. Your associate provided excellent guidance, role playing during inspection readiness and also had good assessment tools. We particularly appreciated how detailed were the reports you provided at the end of the assignment which we could use to refine our audit preparation approaches for future inspections. Thank you and I hope we work together again.

I want to acknowledge your contributions during the last year you joined our group. Mock “deficiency letter” to critical sections of a Biologics License Application, Comment on Expert Reports in Part II and III of Common Technical Document, Provide Strategic Guidance for the Clinical Summary of the acquired XX Vaccine from XX Biologics. In an out of scope project you helped with responses to FDA’s letter. I found you work comprehensive and accurate. Thank you and my best for your continued success.

This is to GBR for Ruchika Raval’s expert opinion in Regulatory Affairs and current trends in the biological therapeutics. She was exceedingly knowledgeable and informed. Her reports were clear and precise. We would like to thank you and hope we can work more frequently.