Black Diamond Regulatory Consulting
Black Diamond Regulatory Consulting, LLC is a consulting firm specializing in regulatory and quality consulting for the pharmaceutical, dietary supplement, food, and related industries. Led by President David R. Schoneker, the company provides expert advice, training, and auditing services to help clients navigate global regulations, develop petitions, and ensure compliance in excipient, food additive, and color additive sectors. The firm is recognized for its expertise in global excipient and food/color additive issues, and it actively participates in international regulatory organizations.
Industries
Nr. of Employees
small (1-50)
Black Diamond Regulatory Consulting
Lansdale, Pennsylvania, United States, North America
Services
Advisory services on global regulatory and quality requirements for excipients, food/color additives, dietary supplements and pharmaceutical applications.
End‑to‑end support for Chinese excipient/API registrations including English dossier preparation, Chinese translations, local dossier preparation by an agent, portal submission, and ChP 2020 compliance assessments.
Third‑party GMP audit services, supplier qualification coordination, audit reporting and recommendations to support supply‑chain quality and compliance.
Customized training sessions and presentations on excipient, food and color additive regulatory and quality topics delivered to industry groups, regulators and academic programs.
Manage multi‑party filing projects, track progress, coordinate with in‑country agents, and perform local regulator interactions including meetings and supplemental submissions.
Validation and verification of analytical test methods and compilation of supportive reports to demonstrate pharmacopeial compliance.
Advisory services on global regulatory and quality requirements for excipients, food/color additives, dietary supplements and pharmaceutical applications.
End‑to‑end support for Chinese excipient/API registrations including English dossier preparation, Chinese translations, local dossier preparation by an agent, portal submission, and ChP 2020 compliance assessments.
Third‑party GMP audit services, supplier qualification coordination, audit reporting and recommendations to support supply‑chain quality and compliance.
Customized training sessions and presentations on excipient, food and color additive regulatory and quality topics delivered to industry groups, regulators and academic programs.
Manage multi‑party filing projects, track progress, coordinate with in‑country agents, and perform local regulator interactions including meetings and supplemental submissions.
Validation and verification of analytical test methods and compilation of supportive reports to demonstrate pharmacopeial compliance.
Expertise Areas
- Excipient regulatory compliance
- Food and color additive regulatory affairs
- Dietary supplement regulation and petitions
- China regulatory registrations and Chinese Pharmacopeia (ChP) compliance
Key Technologies
- Regulatory dossier compilation and electronic submission
- Pharmacopeial monograph comparison
- Analytical test method validation and verification
- GMP audit methodology
News & Updates
FDA amends color additive regulations to allow calcium carbonate in dietary supplement tablets and capsules, resolving a regulatory hurdle for industry.
BDRC partners with a Chinese consulting firm to offer registration, translation, and compliance verification services for excipients and APIs in China.
BDRC received the 2023 Best of Lansdale Award in the consulting category for its community service and business excellence.
FDA seeks comments on establishing a pilot program for toxicological and quality evaluation of novel excipients.
Discussion on the regulatory status and safety of TiO2 in foods and pharmaceuticals, including recent EU court decisions.
Dr. David Warheit concludes that credible safety data supports TiO2 (E171) as safe for use in foods, criticizing EFSA's classification.
FDA amends color additive regulations to allow calcium carbonate in dietary supplement tablets and capsules, resolving a regulatory hurdle for industry.
BDRC partners with a Chinese consulting firm to offer registration, translation, and compliance verification services for excipients and APIs in China.
BDRC received the 2023 Best of Lansdale Award in the consulting category for its community service and business excellence.
FDA seeks comments on establishing a pilot program for toxicological and quality evaluation of novel excipients.
Discussion on the regulatory status and safety of TiO2 in foods and pharmaceuticals, including recent EU court decisions.
Dr. David Warheit concludes that credible safety data supports TiO2 (E171) as safe for use in foods, criticizing EFSA's classification.