Become a “Regulatory Tactician”: Integrating a Regulatory Strategy

Posted on July 23 2014 | Author: Mary Dimou

Whether a start-up or a high-profile brand, regulatory considerations often fall short to the glamour of product development, packaging, and marketing techniques. Regardless of the industry, these considerations are often deferred to the end of projects, potentially leading to compromised standards, which in severe cases, may lead to monetary penalties.Mary Regulatory blog

Entrepreneurs are frequently required to adopt a ‘jack-of-all-trades’ persona, ultimately increasing their susceptibility of overlooking certain critical regulatory requirements. Implementing a strategic regulatory plan can save entrepreneurs’ money and time, facilitate the integration of short-term tactical decision points, and enhance communication with their business team.

Elements of a Regulatory Strategy for Entrepreneurs

A strategic regulatory plan can transform the productivity of a business by simply aligning regulatory considerations with business objectives from the beginning to the end of a project. From the Food and Natural Health Product regulatory perspective, irrespective of whether you are releasing your first or tenth product into the market, reviewing regulatory requirements is essential.

The regulatory affairs’ domain is constantly in flux and a regulatory strategy should be considered a “living document” that can be referenced at every NO/GO decision point of your process from initial prototype to advertising strategy. Defining this process as a “living document” suggests foreseeing deviations to your regulatory strategy regularly and adopting a pragmatic approach to dealing with them.

At various stages of the project, entrepreneurs will encounter both internal and external factors that may alter the regulatory strategy including (but not limited to):

  • Regulations evolving – changes in guidelines, flux of regulatory authorities and standards, consideration of new requirements and legislations available versus those projected
  • Competitive products on the market – viewing the competitive landscape, analyzing the potential players and their location, new intelligence of similar products, recent patents on the market, defining your market position
  • Product development - changes in target label or markets, applying for food safety certifications (Halal, Kosher, Organic, Gluten-Free and GMO-Free) that are most effective in the market and changing manufacturing and distribution practices accordingly
  • Exportation potential – considering international requirements for releasing your product, considering the compliance of particular ingredients – their uses and approval status, updating claims, relevance of certain certifications

Despite these variables, it is imperative to maintain focus on your end goal – using regulations as the catalyst for developing the synergy between clinical, product quality, and business elements.

How You Can Start Developing a Regulatory Strategy

More often than not, entrepreneurs are not aware of the serious time constraint necessary for following the regulatory framework nor the complexity involved in this process. The number of forms, length of applications, and allocation of own time learning regulatory processes can be reduced through an integrated regulatory overlay. This technique will also assist in identifying issues at an early-stage and reduce your workload in the future. Although an expense, connecting with appropriate regulatory consultants throughout the project timeline can also help guide your application with minimal errors and expedite the process of your product launch. Outreaching to pre-market approval and post-market surveillance legislation experts from governmental bodies including Health Canada and the Canadian Food Inspection Agency are also valuable tools in your regulatory strategy and their guidance documents should be visited regularly throughout your process.

Mary Dimou
Graduate Student – Business Analysis Team

Health Canada

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