Select Clients, Colleagues and Recommendations
“Dave is a fine colleague to work with and his energy is unmatched. He will aggressively pursue his passion and remain within the rules of order.”
“Dave is an outstanding ambassador for excipients in the Pharmaceutical industry and the global regulatory arena. I have been privileged to work with him at the International Pharmaceutical Excipient Council, where he was a founder –member, eventually becoming Chairman. He has given me unstinting support on my IPEC committees. In addition to IPEC he is heavily involved in many trade associations where he has influenced global excipient, food additive and colorant regulations and guidance around the world.”
Finished Product Companies
major generic pharmaceutical company
Iid assistance
“Dave provided us with great assistance with the development of a scientifically sound safety bridging justification for the use of an excipient in our ANDA at a higher level of use than currently exists in the FDA’s Inactive Ingredient Database (IID).”
Ingredient Companies
Major Excipient manufacturer
“Dave’s long history with excipients and his significant involvement with IPEC provides great expertise that we want to take advantage of by having him consult for us as an external part of our regulatory team. We are glad to be working with him in this capacity.”
MAJOR GLOBAL EXCIPIENT MANUFACTURER
China registration
We chose to work with Black Diamond Regulatory Consulting, LLC (BDRC) on a recent registration project in China and the process was smooth and successful. BDRC’s knowledge of the industry and understanding of the often-changing requirements for submission into China proved invaluable for our effort. We were able to complete this work in a much shorter time than anticipated and that was due to the ability for BRDC to work with our team to best define the requirements, where the gaps were, and develop the dossier for submission to the China CDE/NMPA. The quality of the dossier resulted in acceptance without request for changes and our product is now available for potential customers to access and use in drug formulations in China.
Others
Major Global consulting network
“The unique expertise that Black Diamond Regulatory Consulting brings to the table related to pharmaceutical excipients and food additives is something that we would like to provide to our clients when they use our network.”
Testimonials
“I highly recommend Dave for his professionalism, knowledge, effectiveness, influence and contacts worldwide in pharmaceutical and food excipient regulatory management.”
“It gives me immense pleasure to recommend David Schoneker, whom I have known for many decades since I started working with Pfizer Global R & D . He has been a great resource for regulatory matters related to pharmaceutical excipients and nutraceutical ingredients. He has in depth knowledge of all the global regulatory authorities, including that of the US FDA. He also heads up activities with Pharmaceutical Excipient Councils. Now that he is an independent consultant, I recommend reaching out to him for any such matters involving regulatory and related matters! I wish him the best in his new “ Consulting career”!”
“I had a chance to work together with David on a project. He has an outstanding knowledge and experience in the pharma industry and works with high enthusiasm. It is my pleasure to recommend him in any pharmacological or nutraceutical matters.”
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Competence and Trust!
You can count on Black Diamond Regulatory Consulting, LLC