Blog Writer

The Importance of Integrating a Robust Regulatory Strategy
Within Your Product Strategy.

Sandra Lourenço
Sandra Lourenço
Director of Regulatory Affairs

Sandra has more than 22 years of expertise in both the Pharmaceutical and Management Consultancy sectors. Throughout her career, she has actively engaged and made significant contributions during the initial phases of medicinal life cycles.

Sandra has successfully led numerous Regulatory consultancy projects on a global scale. Her accomplishments include the submission of over five hundred new abridged Marketing Authorizations in the European Union, utilizing both National and European procedures. This involved comprehensive work on the development of Modules 1, 2, and 3, as well as the adept management and response to deficiency letters. Additionally, Sandra has skillfully overseen the ongoing lifecycle maintenance of these products post-approval.

As your drug development ambitions grow, having a robust regulatory strategy in place from day one – as an integral part of the broader product strategy – is vital so that next treatments fulfil their potential.

Shoring up product success.

As it stands, the probability of success of a product making it from clinical development through to marketing approval is in the range 10–20%. With orphan drugs, that can be considerably lower.

Anything that can help improve this success rate is clearly welcome.

A robust regulatory strategy bridges the gap between science-led innovation and the commercial reality of placing a product onto the market and making it commercially viable in the longer term so that patients benefit.

It provides a roadmap for navigating the product development lifecycle, achieving registration, and sustaining its market success and long-term availability.

Keeping everything & everyone aligned.

The goal of an optimized, integrated regulatory strategy should be to:

  • Streamline the submission process.
  • Achieve a successful and faster product application approval.
  • Reduce the time to launch.

It has a bearing on a wide range of activities and functions beyond regulatory affairs – spanning CMC/quality, pharmacovigilance, medical and marketing. Each has a part to play in bringing a medicinal product to market in its target territories, and keeping it there.

Purpose.

Ideally a regulatory strategy will:

  • Document the plan for navigating from science-led innovation and optimism, through regulatory compliance, and potentially on to its business ROI and market share.
  • Help to highlight when great ideas are unlikely to convert to a robust business model, that will be commercially viable – and sustainably so – if the drug enters the market.
  • Assist, through its design, in the early identification of problems a new product might face in reaching the market, or when on the market – before too much resource has been allocated.

Scope.

A strong, integrated regulatory strategy will anticipate what will be required by the authorities in each target market, starting with the necessary clinical studies for target indications in each territory.

It will ensure that requirements are fulfilled, both pre- and post-marketing, right across the drug development and license maintenance lifecycle. That includes potential risk management and risk mitigation obligations, capacity/contingency planning (e.g. alternative active ingredient – API – sources); the formalities of site transfers; and potential authorization for additional indications.

There are other important factors to consider too, including:

  • Great communication across all stakeholders & senior product strategy and business leaders.
  • Transparency, building trust and fostering the sharing of new insights as they emerge.
  • Compliance – so strategies and plans are progressed in line with evolving and diverging regulations in the different target markets.
  • Consideration of patient interests/patient needs – keeping the end beneficiary at the center of all considerations, and as the main driving force behind any decisions.

Building in all of these considerations can feel overwhelming for a small biotech; even for a large established pharma company that’s previously focused on other areas of drug development.

But expert support is at hand…

To access or download a copy of our new guide:

If you like this guide, then we recommend this webinar here:

free webinar topra
Integrated Pharma Regulatory Strategy as the Key to Market Advantage.

This webinar explains how a unified approach to regulatory affairs can streamline the process, reduce risks, and get innovative treatments to market faster.