Contact

➤ LOCATION

Lansdale, PA 19446

☎ CONTACT

blackdiamondreg@gmail.com
(267) 251-3123

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.