What can Black Diamond do for you?
David R. Schoneker is currently the President/Owner of Black Diamond Regulatory Consulting, LLC, a consulting firm specializing in providing regulatory and quality consulting for the pharmaceutical, dietary supplement, food and related industries. The firm provides expert advice for difficult problems and training on excipient and food/color additive regulatory, quality and supply chain concerns.
If you need help with understanding global regulations as they relate to excipients or food/color additives, registering your excipient or food/color additive product in various countries, developing appropriate petitions or drug master files, getting third party GMP audit advice to assess your manufacturing or laboratory operation, evaluating the GMP compliance of your suppliers, or would like someone to provide training on various global excipient quality or regulatory requirements, then Black Diamond Regulatory Consulting, LLC may be able to help you succeed with your projects.
Black Diamond Regulatory Consulting, LLC is one of the only consulting firms specializing in global excipient and food/color additive issues related to the pharmaceutical, dietary supplement and food industries.
Get in touch with Dave to set up a consultation, or use the contact form at the bottom of this page to enquire whether our services are right for you.
Contact
➤ LOCATION
Lansdale, PA 19446
☎ CONTACT
blackdiamondreg@gmail.com
(267) 251-3123
Areas of Expertise
Pharmaceuticals/excipients
Extensive understanding of global regulatory and quality requirements for pharmaceutical excipients when used in drug products, especially solid oral dosage forms. Actively involved in projects related to Pharmacopeial Harmonization, the FDA’s Inactive Ingredient Database (IID), Drug Master Files (DMFs) and Novel Excipient Safety Evaluations. Currently, I am the Vice Chair of Science and Regulatory Policy at the International Pharmaceutical Excipients Council of the Americas, the Global Expansion Coordinator of the IPEC Federation and a member of the Product Quality Research Institute’s Steering Committee.
regulatory/quality services
Influenced the development of many regulations and guidance documents related to pharmaceuticals, excipients, dietary supplements, foods, food additives and color additives. Known for solving difficult regulatory and quality problems. Helped develop the global excipient GMP standards and guidelines that are used as the industry standard for quality. Assisted in the development of supplier qualification related guidelines for the excipient, non-dietary ingredient and food additive industries. This broad experience can help you with any regulatory or quality projects that you may be struggling with.
dietary supplements/non-dietary ingredients
Experience in development and submission of food and color additive petitions/registrations for dietary supplement uses in many different countries. Performed many global regulatory assessments of non-dietary ingredients to determine appropriate formulations for global dietary supplement applications. Member of the Regulatory Affairs Committee of the Council of Responsible Nutrition and the Consumer Healthcare Products Association. Initiated the development of several industry-specific supplier qualification related guidelines.
auditing services
Performed many audits of excipient, food additive and color additive manufacturers over the years. Coordinated supplier qualification programs with a global team to ensure that appropriate GMPs and specification requirements were being met to provide patient/consumer safety and consistent performance in various applications. Assisted in the development of excipient and food additive GMP audit standards and guidelines as well as various third party certification programs such as EXCiPACT. Audit services can be provided to supplement your own audit programs with a qualified auditor.
foods/food & color additives
Coordinated global regulatory research to build a food additive and color regulations database that was used as the basis of many formulated products around the world. Developed and submitted several food and color additive petitions in various countries and GRAS Notifications in the United States. Past President of the International Association of Color Manufacturers, Board Member of the International Food Additives Council and member of the Supplier Qualification Committee of the Council of Responsible Nutrition. Participated as an NGO Delegate to the CODEX Committee on Food Additives (CCFA) for many years.
training
Excellent presentation skills have facilitated the development of many excipient, food additive and color additive training sessions that have been presented in many countries through various trade associations. Presentations have been given at conferences and workshops internationally. Dave is an adjunct professor in the Pharmaceutical RA/QA program at Temple University’s School of Pharmacy. Training can be provided on many topics and the sessions can be customized to your particular needs.
“Over 46 years of experience in the Pharmaceutical, Dietary Supplement, and Food Industry”
Let's Chat about your issue.
Use the form below to contact Dave regarding your regulatory or quality enquiry. Please be as detailed as possible. Include your industry along with any specific questions and document requests. To help Dave best service your enquiry, we recommend that you first describe the issue or problem you’re having before telling Dave what you want to achieve. If auditing is desired, please explain what type of facility you would like audited. If training is what you would like on a particular topic, please specify what type of training you would like. You may also email or call Dave to make an appointment.