Applying science to
assure success

The healthcare marketplace has become an increasingly competitive business requiring companies to explore targeted and rapidly evolving clinical and regulatory strategies. Innovative Science Solutions, LLC (ISS) represents a new concept in scientific consulting that provides a wide range of scientific support solutions across a variety of business applications. ISS specializes in providing clinical and regulatory support for a wide range of pharmaceutical products, nonprescription drugs, cosmetics and dietary supplements.

Although we tailor all of our scientific support activities to the precise needs of each assignment, this list outlines the range of clinical and regulatory support programs we offer:

Regulatory Strategy Development
The road to the quickest and most effective product approval does not come without careful consideration of strategy and tactics. ISS specializes in providing integrated approaches that maximize the potential for success while minimizing the approval time. Our keen insight and knowledge of the regulatory process allows ISS to add value to a multitude of regulatory interactions.

Regulatory Submissions
Putting together an effective regulatory submission is far from a "turn-key"operation. Careful thought must go into developing a submission that will effectively communicate product features and benefits. ISS has years of experience in helping to prepare the most persuasive regulatory submissions based upon sound scientific data. We have expertise in the design and development of INDs and IDEs as well as PMAs, NDAs, PLAs, and European dossiers.

Manufacturing / Quality Assurance
ISS staff has expertise in the development and validation of manufacturing processes and can assist you in ensuring that they comply with the appropriate regulations, including GMPs.

Advisory Committee Programs
ISS specializes in turnkey advisory committee support programs, allowing our clients to be guests at their own FDA advisory committee hearings. From strategy development to the creation and projection of visual graphics, ISS handles all the elements critical to a successful advisory committee review.

Clinical Development
ISS has expertise in developing clinical testing programs to support safety, effectiveness and claim basis for new and existing products. Protocol writing, site selection, monitoring and auditing are just a few of our services. These offerings are rounded out with biostatistical and epidemiology resources.

Rx to OTC Switch
Members of the ISS staff have participated in the clinical and regulatory development of the majority of successful Rx to OTC switch initiatives. Our keen appreciation of the important dynamics between consumers, regulators, investigators, and the medical community allows us to assist our clients with the most challenging, cutting edge switches.

To print this in the form of a data sheet, click here.