CHICAGO, IL, October 16, 2017 – OneSource Regulatory (OSR), the premier specialized technology-enabled professional services firm, today announced a free technology solution for individuals working in the life sciences industry, with the launch of MyIndago.
MyIndago is the most effective solution for professionals working in the highly-regulated FDA environment, striving to help pharmaceutical companies maintain compliance. With MyIndago, individuals can easily search and access FDA enforcement communications to gain transparency into what has been problematic according to the FDA. Typically, this information is posted by the FDA at the time of communication and can be accessed on their webpage, but it is not easily searchable or cataloged within a user-friendly environment. Instead of a high-priced subscription database, available only to employees in the largest organizations, MyIndago is a free solution available to everyone.
Co-founder and visionary of OSR, Tracy Rockney, speaks to the value of MyIndago as an innovative technology: “With MyIndago, accurate information is readily available to empower decision-making to anyone, at all levels of the organization.”
“Indago is Latin for investigation, searching, or seeking.., which is exactly what we wanted to equip our peers with by creating MyIndago. We have deep experience with FDA advertising and promotion review and are interested in solving problems and leading a dialogue. With MyIndago, there is an opportunity to support a community of users by offering professional insights with others in the industry.”
Currently, MyIndago contains over 3,500 enforcement communications from:
- FDA Office of Prescription Drug Promotion (OPDP)
- FDA Advertising and Promotional Labeling Branch (APLB)
- FDA Center for Device and Radiological Health (CDRH)
- Dietary and Nutritional Supplements
- Center for Veterinary Medicine (CVM), Animal Health
- US Corporate Integrity Agreements (CIA) and OIG Advisory Opinions
- FDA – Cosmetics (Topical Skin and Hair Care Preparations, Eyelash and Eyebrow Treatments)
- FDA Advertising & Promotion Regulations/Guidance Documents
These sources are now available for search and discussion within MyIndago and additional enforcement actions are scheduled for addition in the near future, including actions from regulatory bodies outside the U.S. MyIndago is a global solution for understanding the regulatory perspective for global product companies, who also need to understand specific legal and compliance jurisdictional considerations.
OSR Innovator and Co-Founder Rob Merrill: “MyIndago helps achieve OSR’s mission to bring innovation to our industry by providing free tools for professionals as consumers – technology to help individuals do their work better. And, with OSR’s team of reliable and dependable experts, MyIndago facilitates an exchange of ideas and best practices among users – providing regulatory services and advice at the simple click of a button. Expect to see more technology resources and solutions from us in the coming months as we expand to become the leading provider of intuitive, cutting-edge solutions for our industry.”
OneSource Regulatory (OSR) is the premier leader in providing Regulatory, Medical and Healthcare Compliance services and solutions for the pharmaceutical and biotechnology industry. Leveraging expertise from decades of proven industry experience, OSR provides the following services: Regulatory and Medical Affairs and Commercial Healthcare Compliance.