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Product Development Strategies
The Weinberg Group provides comprehensive guidance and support through all phases of a product’s lifecycle. The hallmark of our efforts in Product Development is to guide clients in making the critical decisions that impact both the speed and cost of development. And, if the client lacks the internal resources, we also can serve as a total turnkey operation to implement developmental strategies. The following are some of the services we provide in this area:
- Develop business strategies that capitalize on a well-designed development plan through astute use of clinical and epidemiologic data
- Identify scientific evidence to establish and support product value, reimbursement and promotional claims
- Design, place, and monitor nonclinical safety studies for dietary supplements
- Design, place, and monitor clinical safety and efficacy studies for dietary supplements
- Develop strategies to obtain approval of drug claims for dietary supplement products
- Conduct comparative risk analyses, using widely accepted Practices, to demonstrate the relative safety of new and existing chemical formulations.
- Anticipate coverage, coding, pricing and reimbursement hurdles
- Design and analyze preclinical, clinical, epidemiology and biocompatiblity studies
- Manage client-sponsored contract research
- Manage data, analyze statistics and prepare Integrated Clinical and Statistical reports
- Proactively initiate efforts to expand labeling, product enhancements and regulatory compliance
- Monitor both FDA’s and EPA’s evolving regulatory agendas and other indicators of policy initiatives that could pose new hurdles to product development, testing, compliance, marketing or disposal of materials.
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