• Regulatory Strategy Development ISS specializes in providing insight and knowledge of the regulatory process as well as integrated approaches that maximize the potential for success while minimizing the approval time. Click here for a case study
• Regulatory Submissions ISS helps to prepare persuasive regulatory submissions based on sound scientific data. This includes design and development of INDs, IDEs, PMAs, NDAs, PLAs, and European dossiers. Click here for a case study
• FDA Drug & Medical Device Advisory Committee Review ISS handles all the elements critical to a successful advisory committee review from strategy development to the creation and projection of visual graphics. Click here for more details or Click here for a case study
• Clinical Development ISS develops clinical testing programs (protocol writing, site selection, monitoring, auditing, etc.) to support safety, effectiveness and claim basis for new and existing products. These offerings are rounded out with biostatistical and epidemiology resources.
• Rx to OTC Switch ISS appreciates the dynamics between consumers, regulators, investigators, and the medical community. This allows us to assist with even the most challenging, cutting edge switches.
• Technology Identification/Lifecycle Management ISS identifies, evaluates, and conducts due diligence assessments of in- and out-licensing technologies. ISS also represents firms in the pursuit of strategic partnerships and develops integrated strategies for maximizing return on product investment. This includes patent and exclusivity extensions, new indications, forms, claims, and Rx to OTC switch.
• Issues Management/Influence Programs ISS builds initiatives and outreach programs that facilitate product acceptance and market success, as well as, influencing prescribing behavior.
• Medical Information Services ISS has developed a web-based solution that allows a firm’s medical information team to quickly and efficiently manage and disseminate information.
• Dietary Supplement Claim Substantiation and Defense Services ISS crafts scientific substantiations using the most reliable scientific evidence to provide a rational basis for dietary supplement claims. Click here for more information or Click here for a case study

For more information contact Steven Weisman, Ph.D, Head of Global Healthcare Products