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Our professional colleagues have extensive background and experience in the following sectors:
- Drug (Rx and OTC)
- Dietary supplement/nutraceutical
- Medical device
- Cosmetics
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We also have extensive experience interacting with the FDA, in the U.S. and abroad, with expertise in regulatory affairs and compliance, Quality Assurance, Quality Control, analytical chemistry, formulation development, clinical trials monitoring, formulations, Active Pharmaceutical Ingredients (APIs), excipients, and all finished dosage forms.
Principals:
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Commitments To Our Clients:
- To use our extensive background and broad-based experience in the industry and with FDA to give clients a clear sense of direction and purpose for all facets of GMPs, GCPs, GLPs, and GXPs.
- To lead clients towards compliance to FDA, WHO, MHRA, SFDA, Japanese, and other international GMP requirements.
- To provide and teach correct principles, and to empower clients with the knowledge and skills to successfully manage compliance internally.
- To demonstrate excellence in consulting, training, knowledge, and in our service to clients.
- To lead by example; our leadership is characterized by honesty, truthfulness, and integrity.
- To develop client’s skills, to adapt to changing requirements and priorities.
Over the course of our consulting careers, we have prepared or co-authored a variety of pertinent papers that have helped our clients. The papers include understanding aspects of eCTD, quality policies, and a legal review response article regarding the new Dietary Supplement GMP Regulations. |
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