Ever since the inherent risk in the marketing of medical devices and drugs increased, establishment of a tailor-made regulatory strategy for business success has been the call of the hour. The global environment has become pervasive because of the growing complexity in the pharmaceutical devices.  Ultimately the regulation and market adoption of those avant garde drug/devices have adopted the same speed. While a well-prepared regulatory strategy will put the brakes, this post offers important factors to consider for better regulatory strategies in pharma companies.

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Progress is impossible without change ~ George Bernard Shaw

The drug/device market is in constant evolution induced with latest technology and plausible risk as well. Poor knowledge and piecemeal outlining can eventually result in delays, surmounting of budget and business catastrophes on the whole. Therefore, it has become essential for regulatory professionals to have a knowhow on existing requisites and latest developments in the global market.

Besides, pharmaceutical companies must make an all-inclusive estimation of both local and global market. Existing regulatory environment along-with responsive and effective strategies should also be brought into consideration for overall business objectives.

Today regulatory strategy plays a pivotal role in the initial stage of planning & developing various drug products. And with the constant growth in the market, the Government regulations of any given country also modify accordingly. This type of change and growth has enabled the regulatory strategy a major success factor in the marketplace.

A thorough knowledge about the global stipulation from the viewpoint of regulators, healthcare providers and patients has become a must-have necessity while outlining a global regulatory strategy. That’s because development and successful marketing of any drug product is now directly proportional to the regulatory game plan.

To add on, the International Conference on Harmonization (ICH) has modified the processing of the approval applications for marketing of drug products. Therefore, a clear understanding of the challenges and objectives is necessary while designing a global regulatory strategy.

What is regulatory strategy?

A regulatory strategy is a sanctioned document tantamount to the regulatory affairs. Its key role is to introduce a re-examined medical equipment to the market through an excellent marketing strategy. The regulatory strategy process also offers an extensive clarification of the product, whilst addressing the significant regulatory elements of quality assurance.

Basics of regulatory strategy for those entering the area of global drug development

  • Synopsis of the regulatory considerations – Beginners should understand the synopsis of the regulatory considerations in the melting pots of the globe where marketing applications are searched for
  • Declaration of the regulatory tools – Beginners should have a thorough knowledge on the regulatory “tools” that professionals require
  • Remuneration considerations – Newcomers should also understand how remuneration considerations affect a global development strategy and regulatory strategy alike
  • Role of the regulatory professional – Finally, newcomers should have a clear understanding about the role of the regulatory professional in cross-functional strategy teams

The above knowledge is crucial while conceiving a global regulatory strategy to market any newly developed drug/device.

Key elements of regulatory strategy

Developing an effective and competitive regulatory strategy is the most challenging aspect for any regulatory professional. That’s because this process involves the following -

  • Estimation of regulatory risk
  • Taking decisions on type of filings
  • Labeling approach
  • Content usage
  • Timing for submissions
  • Meetings with regulatory bodies
  • Approval metrics
  • Development of target promotional claims
  • Detecting issues

A winning regulatory strategy should begin with end in mind

This suggests the game plan, which is outlined at the beginning of the project, should be modified as per the induction of new data and current market trends.  Most of the US pharmaceutical companies find this strategy a feasible method for developing their medical equipment that are validated through Quality System Regulation design controls.

The above mentioned key elements create a platform for the regulatory plan. And this plan enables a pathway for achieving regulatory goal, such as approval by FDA for marketing the device. To summarize, the regulatory strategy integrates the development plan of the drug/device. It also highlights on the unresolved issues of the earlier versions of the device, apart from providing detailed background information and guidance credentials on implementation.

Internal factors to consider for regulatory strategy

An exhaustive clinch of the assorted internal factors is required to conceive an integrated regulatory strategy. Following are some of the internal factors to consider for regulatory strategy -

  • Market objectives
  • Company’s position in the space
  • Degree of progress of the completed work
  • History of similar products
  • In-depth knowledge on technology and mechanisms involved
  • Resource availability i.e. time, staff, expertise and money
  • Communication with other development projects
  • In-house vs. outsourced development efficiency
  • History of discussions with regulatory authorities
  • Remuneration strategy
  • Strategic evidence development

External factors to consider for regulatory strategy

A product is never launched into an oblivion

Therefore, a prerequisite for outlining a powerful strategy is a must that comprises of an all-inclusive estimation of the current external factors that influence the regulatory strategy process. Following are some of the external factors to consider for regulatory strategy -

  • The competitive prospect
  • Trending medicine practices and healthcare standards both local and global
  • Business concerns with specific drug/device categories
  • Changing regulatory environment that includes submission procedures, modification in classification and evidence requisites
  • Health of the device and analytical estimation on effectiveness
  • Remuneration policies
  • Quality assurance of specific materials and components
  • Result of off-label use

So those were our top picks on important factors to consider for better regulatory strategies in pharma companies.

At Freyr, we produce and support regulatory-technique oriented and product-specific global regulatory strategy for companies who are into development of drugs, vaccines, biologics and cosmetics.


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