Innovative Science Solutions is a team of skilled scientific and regulatory consultants that deliver distinctive approaches to fulfill the complex business needs of industry and counsel. Blending scientific expertise and business acumen, ISS integrates strategy, support, and analysis for regulated products to provide results-driven solutions with superior outcomes.

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FDA Advisory Committee Support

Millions of dollars are riding on your FDA Advisory Committee meeting. Any misstep can affect approval likelihood and timing. Be prepared. ISS can help ensure a timely approval at your next Advisory Committee meeting by providing an integrated approach to managing all aspects of the meeting for your product.

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FDA Advisory Committee Support

Clinical Strategy Development

ISS has expertise in developing clinical programs to support safety, effectiveness, and the basis for marketing claims for new and existing products. Our clinical strategy services include support for all FDA regulated product types, including Rx and OTC drugs, medical devices, foods, cosmetics, and dietary supplement products.

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Clinical Strategy Development

Regulatory Meetings and Submissions

ISS specializes in providing insight and knowledge of the regulatory process as well as integrated approaches that maximize the potential for product success, while minimizing approval time. ISS helps to prepare persuasive regulatory submissions based on sound scientific data.

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Regulatory Meetings and Submissions

KOL Identification & Advocacy Development

Key Opinion Leaders (KOLs) play a critical role for pharmaceutical and biotech companies during all phases of the product life cycle. KOL needs evolve with life cycle stages and are essential for providing crucial insights for programs related to your products.

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KOL Identification & Advocacy Development

Label Compliance & Claims Support

ISS offers robust regulatory and scientific support services for healthcare products of all types, with an emphasis on label review and claim support. ISS ensures label compliance across OTC drugs, devices, foods, dietary supplements, and cosmetics and provides comprehensive substantiation for label claims.

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Label Compliance & Claims Support

Quality Systems Development

ISS offers comprehensive quality and manufacturing support services to clients involved in the manufacture and distribution of consumer healthcare products, including OTC drugs, dietary supplements, cosmetics, and medical devices.

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Quality Systems Development

Products in Crisis

Attacks on healthcare products come in many different forms, including legal actions, actions by regulatory agencies, governmental investigations, and attacks in the court of public opinion. ISS is skilled at working with product stakeholders to manage these crises and help to provide a path forward.

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Products in Crisis

Support for Product Mergers and Acquisitions

ISS conducts due diligence for licensing deals and mergers and acquisitions for early development, new-to-market, and mature products. As part of this service, ISS assesses the competitive landscape, major unmet needs, and market share for a given product or therapeutic area.

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Support for Product Mergers and Acquisitions

Expert Testimony on Regulatory Matters

High stakes disputes involving pharmaceuticals, medical devices, cosmetics, foods, and other healthcare products often require the testimony of an expert witness that has deep expertise working within the FDA regulatory framework. Our experts provide opinions and educate juries as to the industry standards for how companies typically interface with the FDA and the appropriateness of regulatory activities that have been undertaken by stakeholders.

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Expert Testimony on Regulatory Matters

Let’s work together

The journey to scientific and commercial success is often complex and always critical. If you are looking for an experienced partner to help steer you to confident business solutions firmly rooted in science, contact us today.

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