IDENTIFY, CLASSIFY AND COMMUNICATE
The Drug Information Association (DIA) defines Regulatory Intelligence as: The act of gathering and analyzing publicly available regulatory information. This includes communicating the implications of that information, and monitoring the current regulatory environment for opportunities to shape future Regulations, guidance, Policy, and legislation.
Less formally stated regulatory strategy means: identify, classify and communicate current and prospective regulatory requirements that are relevant to a specific company.
Thus, changing the regulatory scenario in a country can impact the overall regulatory strategy of a Company; no matter the definition, this is hard to do and too often done only after the fact or in an ad hoc manner.
Governments across the region are changing and evolving their Regulatory environments in response to global and local demands. Change is certain. How each change impacts your products may be uncertain and an unpleasant surprise unless you’re working with IRISGLOBAL country experts.
Regulatory Intelligence Briefings: a report and a complete assessment of the accurate status of the company's products that are complying with current standards and short-term future standards.
Opinions / Recommendations to Meet Requirements: What measures are regulatory bodies demanding and what strategies should be taken into account today to reduce the risk of a negative impact?
Emerging Expectations and Trends: Before a regulation changes, the health authorities are usually signaling how their thoughts and expectations are evolving.
New Legislation, Regulations and Guidelines: Know the new laws and regulations, while bills and documents are going through the process of legislation and regulation.
The Impact of Evaluating: The impact of new laws and regulations on company products, processes and strategies.