Clinical and Regulatory
Achieve timely healthcare product approvals and introductions, maximize market potential of existing products, comply with regulations, and defend products from science-based challenges. Our team of skilled scientific and regulatory consultants, including former FDA and certified quality auditors (CQA holders), deliver distinctive approaches to fulfill the complex business needs of industry and counsel. Blending scientific expertise and business acumen, we integrate strategy, support, and analysis for regulated products to provide results-driven solutions with superior outcomes.
We specialize in providing insight and knowledge of the regulatory process, with integrated approaches that maximize the potential for product success while minimizing approval time. We help our clients to manage risk and unlock value by engaging effectively with health authorities, regulators, and external stakeholders. Our experts provide insights on how to streamline, enhance, and integrate a strategy to maximize benefits and reduce regulatory risks.
- Regulatory strategy and meetings
- Regulatory submissions and meetings
- Label compliance and claims support
- Product listings, federal and state registrations
- Key thought leader (KTL) identification and advocacy development
Millions of dollars are riding on your FDA Advisory Committee Meeting/EMA Oral Explanation Meeting. Any misstep can affect the likelihood and timing of approval. Our team can help ensure a timely approval by providing an integrated approach to managing all aspects of an FDA Advisory Committee/EMA Oral Explanation Meeting for your product. We provide a one-stop solution for all the mission-critical elements and deliver services including:
- Scientific data review
- Regulatory strategy
- Key messages definition testing and implementation
- Key deliverables development and creation support (e.g., core presentation, briefing book, backup slides, etc.)
Developing and implementing an effective quality management system is key for supporting and maintaining GxP programs. Implementing a streamlined and flexible approach to quality will ensure long-term compliance and risk mitigation. Our experienced team can help enable the best possible outcome for your study and assessments. Using our extensive network of experienced quality consultants, we can provide support for quality and compliance in the prescription, over-the-counter, medical device, cosmetic, and dietary supplement industries. Our agile team of quality consultants can serve as a complete Quality Department, as well as provide support and guidance for specific needs and projects.
- Quality management system development and implementation
- Due diligence auditing
- Supplier GxP auditing
- Quality metrics and development of key performance indicators (KPIs)
Developing effective preclinical and clinical development strategies is key for optimizing business impact. We provide strategic support for all FDA- and EU-regulated product types, including prescription and over-the-counter drugs, medical devices, foods, cosmetics, and dietary supplement products. Lumanity also provides scientific due diligence assessments for company or product acquisitions, including in- and out-licensing of technologies.
- Design and oversight of preclinical and clinical strategies
- Clinical protocol writing and development
- Vendor selection and management
- Assessment of study designs and applicability to product’s goals
Companies often need guidance to determine whether their advertising content is adequately supported by competent and reliable scientific evidence. When it is not, product sponsors often require help revising their copy to better align with the evidence and to ensure that they are making well-substantiated marketing claims. When marketing copy is not adequately supported, it can result in serious consequences, including regulatory action by the Food and Drug Administration (FDA) or the Federal Trade Commission (FTC). Lumanity is your trusted partner in product stewardship.
- Scientific substantiation of marketing claims
- Marketing claims review and claim language development
- Ingredient safety assessment
- FDA claims notification
High stakes disputes involving pharmaceuticals, medical devices, cosmetics, foods, and other healthcare products often require the testimony of an expert witness who has deep expertise working within the FDA regulatory framework. Our experience working at the intersection of government regulatory agencies and industry executives has enabled Lumanity to cultivate a deep, contextual knowledge of issues related to healthcare product commercialization, product safety issues, and regulatory challenges.
- Regulatory challenges (e.g., Federal Trade Commission (FTC) and National Advertising Division (NAD)) involving a product’s marketing claims
- Legal actions involving allegations that an FDA-regulated product is unsafe, ineffective, or inappropriately manufactured
- Legal challenges to intellectual property protection
- High stakes commercial disputes involving FDA regulated products
We would love to hear your challenge and discuss how our clinical and regulatory experts can help.