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Regulatory Strategy and Assessments

Fundamental to successful commercialization is the regulatory strategy which must begin early in product development planning.

At G&L Scientific, our regulatory professionals have perfected the approach by reverse engineering the strategy, using the desired drug label as driver.

Considering the therapeutic landscape, standards of care, and possible expedited regulatory pathways, the drug candidate is assessed in order to maximize regulatory probability of success (PoS). Depending on where it falls in the spectrum and, of course, the data, G&L’s commitment is to get the PoS to a minimum of 50%, with the goal of 75% or greater.

Focused on the process

The regulatory strategist assigned to your team will begin by providing an assessment report that typically begins with an extensive gap analysis.

Regulatory strategy is constantly evolving as new data are made available. Depending on where the drug candidate is in the continuum of its development program, G&L may recommend that the team routinely engages the process of identification of regulatory risk. This exercise essentially evaluates what has been communicated by the health authorities against what your company has done or has decided not to do. We like to call it ‘conducting good regulatory hygiene.’

We have found that many of our clients request this approach so that the cross-functional team of subject matter experts does not lose momentum in the stage-gate process (e.g., feasibility to launch). It also provides an opportunity for Agency engagement beyond the prescribed milestone meetings.

Our expertise in building a Target Product Profile (TPP) has often been credited as the game changer in highly effective and collaborative Health Authority interactions. Developing the TPP at an early stage ensures transparent communications with key external stakeholders, such as the regulatory bodies and corporate decision-makers including executives and investors.

Our success has validated the initial assumption that creating TPPs, benefit-risk, and other assessments, averts delays to market, reworking expenditures and frustrations often faced by R&D.

Relied upon

Noting that G&L provides end-to-end regulatory consultancy to Fortune 100 companies and smaller biopharms alike, we are often asked to conduct early asset assessment as well as indication assessments, both of which serve to inform portfolio ROI and go/no-go decisions.

Experienced in market valuations, we are prevailed upon by both established pharma and incubator firms to co-create development plans and conduct pipeline assessments, so that investment variables, such as human and financial capital, are rightly appropriated where the probability of regulatory approval is highest.


With ‘Right to Try’, and the incentives given to the industry, there is no shortage of opportunities in the area of rare diseases.

At G&L, we understand that patient advocacy groups are critical in developing Patient Reported Outcomes (PROs), leading to the identification and validation of surrogate biomarkers.

As such, clients rely on our regulatory professionals to navigate new terrain where established endpoints often do not exist. Of course, G&L takes the relationship between ‘Sponsor’ and ‘Health Authority’ very seriously, and we are recognized for accurately presenting data in a compelling data-driven, storytelling manner that facilitates a collaborative relationship. Our patient-centric approach provides the patient’s perspective along with clinical data, yielding favorable regulatory results.

While scientists tend to be linear thinkers, our seasoned regulatory strategists have been carefully selected as they must have expansive thinking, holistic mindsets, and the technical skillset to look at the drug candidate from many angles, wherever it is in development.

From inception to commercialization, our regulatory leads understand the importance of speed to market without sacrificing the integrity and quality of the regulatory submission deliverable.

Our services include:

  • Benefit-Risk
  • Competitive landscape/global market analysis
  • Development plans (build and/or review)
  • Due diligence (M&A)
  • Endpoint (biomarker)
  • Gap analysis
  • Identification of Regulatory Risk
  • Indication assessments
  • Incubator assets
  • Product Ideation/early asset development
  • Portfolio (pipeline) analysis
  • Global Regulatory intelligence
  • Target Product Profile
  • Regulatory Road Maps
  • Clinical Development Plans

Contact us today

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