To stay current with the rapidly changing landscape, regulatory professionals must continuously monitor and identify relevant regulatory information, and that is not an easy task. Constant change, new technologies and products, regional differences, expansion and harmonization, increased requests for transparency by regulatory agencies and regulatory information overload, all highlight the necessity for the implementation of the Regulatory intelligence in your daily work.
Regulatory intelligence is the process of gathering and analyzing targeted regulatory information and data in order to produce a desired output, including identification of potential pitfalls and opportunities and creation of the appropriate regulatory strategy. In its various forms, everyone requires Regulatory intelligence: large pharmaceutical companies and regulatory agencies but also mid-size and smaller biotech and medical device companies.
Main benefits of the Regulatory intelligence are timely identification of risks and opportunities, reduced development costs, faster development and increased compliance. There are various sources of regulatory information: laws, rules and regulations, guidances, approval and warning letters, regulatory and business development web sites, databases, articles, blogs, press releases, regulatory networks, social media, webinars, publications, paid and free subscription services…. Also, you might use your internal resources, including information from your colleagues, proprietary databases and research tools, past experience and regulatory repositories.
However, the collected data and information should be filtered, arranged, analyzed and summarized by regulatory experts in order to create a desired output and turn information into intelligence. The outputs of this exercise could be strategy proposals, regulatory reports, gap analysis, plans, presentations, due diligence and competitor analysis summaries, proposals, overviews etc.
Regulatory intelligence is frequently used to assess the likelihood of success of own regulatory strategy, especially when there are competitors with similar product(s) in similar or same indications. Also, it is indispensable part of any due diligence activity in relation to in-licensing opportunities. It could be used for preparation of a dialogue with regulatory authorities and to support justification of your position, especially in novel indications and if your deviate from normal practices. It could also help you to establish or investigate your internal regulatory key performance indicators.
Phortas was asked to investigate whether there are previous instances of novel regulatory approaches and/or deviations from standard practices in determining clinical outcome assessments as primary endpoints for a rare disease. Collection of data relied on search for FDA/EMA approved medicines in indication of interest, published literature and analysis of endpoints used in development programs. Results were analyzed and put into right context allowing informed decision making in terms of designing an adequate development program.
A small biotech company required us to prepare a report on Regulatory Competitive intelligence for cystic fibrosis products on US and EU markets. Phortas has created tabulated overviews of all products approved in the EU and US, all products having an Orphan Drug Designation (ODD) status for treatment of cystic fibrosis and analyzed their development status as published on https://www.clinicaltrials.gov and https://www.clinicaltrialsregister.eu/ as well as the WHO register https://apps.who.int/trialsearch/
Phortas has vast experience in providing strategic, ongoing and ad-hoc Regulatory intelligence support to the satisfaction of our clients. If you need a dedicated Regulatory intelligence expert, don’t hesitate to contact us, we are happy to support you.
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