Shaping the future of your business
Utilizing our expert subject matter insights to provide
clear, unbiased strategic advice to our clients.
Shaping the future of your business
Planning for tomorrow starts today
At G&L Healthcare Advisors, we believe that a focused, thoroughly planned regulatory strategy is the essential foundation of successful commercialization.
Careful planning, innovative thinking and development focused on the specific needs of our clients are at the heart of everything we do.
These are integral to the design and delivery of our range of services and solutions and form the backbone of our strategic consultancy offering.
Utilizing the skills, experience and subject matter knowledge of our global Regulatory Affairs professionals, we are uniquely positioned with an unrivaled knowledge of local regulatory legislation and intricacies.
This is bolstered by the experiences and insights of our entire global team to guide every client and their project to success.
At a glance
- Analysis-driven regulatory strategy, specific to every client
- Expert delivery of all regulatory activities and filings
- All services underpinned by a granular understanding of Regulatory Affairs, Quality Assurance and Clinical Development
Gap analysis first, then strategy
By assigning a dedicated regulatory strategist to your team, we are able to get a greater insight into your organizational needs and produce a thorough assessment report that uses extensive gap analysis to identify exactly where support is needed most.
This ensures all our strategic recommendations are suited exactly to each client's specific needs and are directly informed by our holistic analysis of your entire organization.
Good data = great results
When it comes to our strategic solutions, data is at the heart of everything we do.
As a result, we are recognized for accurately presenting data in a compelling data-driven, storytelling manner that facilitates a collaborative relationship with everyone with whom we work.
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 to ensure they have expansive thinking, holistic mindsets, and the technical skillset to look at the drug candidate from many angles, wherever it is in development.
At G&L, we believe that, regardless of size or stage of development, every client is our number one priority.
As a result of our industry expertise, we are called upon by a rich variety of clients to provide them with bespoke services and solutions.
From established pharma and Fortune 100 companies to incubator firms, we 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.
We are also adept at conducting vital early asset and indication assessments that allow clients to get greater insights into portfolio ROI and go/no-go decisions.
Moving with the times
Regulatory strategy is constantly evolving...and so is G&L.
Through our commitment to conducting good regulatory hygiene, we regularly evaluate what has been communicated by global Health Authorities against what our client has done or has decided not to do.
By routinely engaging in this process of identifying regulatory risk and keeping a weather-eye view and being up to date on the latest trends and topics in regulatory, we are able to better advise our clients on essential changes that may be required to their product development plan.
Such are the time- and cost-saving implications of these exercises that we find many of our clients specifically request them from us.
Not only do they help ensure the cross-functional team of subject matter experts does not lose momentum in the stage-gate process, they also provide an opportunity for Agency engagement beyond the prescribed milestone meetings.
Understanding Health Authority requirements
No matter where in the world your product market is, a solid understanding of the intricacies of each specific Health Authority and how they work is essential.
At G&L, we believe that local knowledge is a vital component of the route to market and a key ingredient in our excellent relationships with Health Authorities throughout the world.
Our expertise in building a Target Product Profile (TPP) is highly effective in collaborative Health Authority interactions.
Developing the TPP at an early stage ensures transparent communications with key external stakeholders, such as regulatory bodies and corporate decision-makers.
Our continued success has proved that utilizing TPPs, benefit-risk, and other assessments averts delays to market, reworking the expenditures and frustrations often faced by R&D.
We are also adept in the entire Regulatory submissions process and providing clients with highly important post-approval work and support.
Our Strategic Consultancy is underpinned by unrivaled subject matter knowledge in every key area of Regulatory Affairs, Quality Assurance and Clinical Development.
- Regulatory strategy roadmaps and program assessments
- Regulatory fundamentals (educating stakeholders)
- Gap Analysis
- Global major filings including simultaneous submissions
- Clinical trial plans and applications (IND, CTA)
- Nonclinical foundations (animal and PK modeling)
- Health Authority interactions (scientific/parallel advice, FDA milestone meetings)
- Advisory boards
- Designations and expedited pathways
- Global pediatric development plans
- Chemistry, Manufacturing and Controls (CMC)
- Medical and scientific (regulatory) authoring
- Risk management plans and labeling
- Small molecules, biologics, cell, and gene therapy
- Global market analysis and regulatory intelligence
- R&D plans
- Due diligence (asset evaluations, M&A)
- Portfolio analysis
- Label expansion (indication assessments)
- Discover and early-stage viability evaluations
- Target Product Profile (TPP)
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Designing and running regulatory strategy
"The development of a G&L G&L multidisciplinary team, including Regulatory, Companion Diagnostics, and Clinical experts, to integrate into the client's team and successfully author and submit the essential Briefing Book.
We worked with the client’s development team to author and submit the Type B EOP2 Meeting Request and Briefing Book."
Medium-sized Biotechnology company