GAP ANALYSIS SERVICES
Accelerate Regulatory Success with a Low-Cost R&D Approach
Small life sciences companies often struggle to strike a balance between scope and complexity in their product development plans. A gap analysis reveals whether your plan is well-structured or if there are critical areas that need refinement. It provides a clear assessment of your readiness to submit to FDA and highlights gaps that could impede a successful IND/IDE, NDA/BLA, or medical device application.
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WHY GAP ANALYSIS SERVICES ARE CRITICAL FOR SMALL LIFE SCIENCES COMPANIES
Developing drugs, biologics, medical devices, and combination products for FDA approval is a complex process. Some companies have development plans that fall short of their targets, failing to meet critical objectives. The right gap analysis can align R&D development with intended product claims and market position, creating a clear, strategic path to both FDA success and commercial impact. Gap analysis services also provide an objective evaluation of your program, identifying missing elements, unnecessary steps, and potential risks.
EFFICIENT DEVELOPMENT
Evaluate your program against regulatory requirements and precedent. Gap analysis services clarify which activities are essential, identify what is missing, and eliminate unnecessary steps.
COMPETITIVE ADVANTAGE
Differentiate your products. Gap analysis services enable teams to carve out a strategic position in the market.
COST AND TIME SAVINGS
Aligning with regulatory requirements early can reduce rework and costly delays. Our gap analysis services identify and address gaps in your development plan, helping prevent budget overruns and eliminating unnecessary steps or processes.
PEACE OF MIND
Gap analysis services provide focused guidance at every stage, uncovering potential challenges early through a clear understanding of regulatory and development requirements. They offer actionable strategies to mitigate high-risk gaps, keep your development on track, and reduce the risk of costly setbacks.
ACTIONABLE OUTCOMES
Gap analysis services produce a prioritized list of gaps with recommended next steps, estimated time, and projected costs, creating a clear roadmap for achieving regulatory milestones and commercial objectives.
FACET GAP ANALYSIS CONSULTING SERVICES INCLUDE:
Nonclinical Gap Analysis
Review nonclinical data, including toxicology, pharmacology, and study designs, to ensure alignment with regulatory expectations.
CMC Gap Analysis
Assess the completeness and adequacy of CMC documentation, manufacturing processes, and quality control systems for the stage of development.
Clinical Gap Analysis
Evaluate clinical development programs, including trial design, patient populations, endpoints, and regulatory compliance for safety and efficacy.
Regulatory Gap Analysis
Review regulatory strategies, submission readiness (IND/IDE, NDA/BLA), and ensure alignment with applicable regulations and special designations (BTD, orphan, small business).
Post-FDA Approval Gap Analysis
Identify regulatory and developmental gaps related to post-approval activities such as new indications, line extensions, or labeling changes.
Tactical Gap Analysis
Assess operational processes, including internal teams, CROs, CDMOs, and other strategic partners, to ensure efficiency and alignment with development goals.
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ENSURE YOUR DEVELOPMENT PROGRAM STAYS ON TRACK
Identify potential gaps and optimize your development strategy. Speak with our experts about how gap analysis services can provide a roadmap of your path to FDA approval.
SCHEDULE A GAP ANALYSIS CONSULTATION
SCHEDULE A GAP ANALYSIS CONSULTATION
Gain Confidence with a Trusted Advisor
Small life sciences companies often feel uncertain about taking the next step in their regulatory program. Facet Life Sciences provides the guidance and expertise you need to prepare for success and avoid common pitfalls. Our team is here to answer your questions and ensure you're fully prepared for every milestone.
Gap Analyses Are Low-Cost and Highly Effective
Facet recommends conducting a gap analysis at each key regulatory milestone (pre-IND, pre-Phase 3, pre-submission) to maximize your chances of success. This proactive approach helps identify critical gaps early, ensuring you're on track for a smooth regulatory journey.
Benefits of Working With Facet
HANDS-ON EXPERIENCE
With decades of real-world expertise in the life sciences industry, our team of scientific and entrepreneurial professionals provides expert guidance throughout your development journey.
PROVEN TRACK RECORD
We have a history of helping clients successfully navigate the FDA approval process, ensuring timely submissions that meet regulatory requirements and industry standards.
CUSTOM SOLUTIONS
Facet understands the unique challenges smaller R&D companies face. We offer tailored solutions that help you navigate regulatory and development challenges efficiently, keeping you on track for success.
PERSONALIZED GUIDANCE
From IND/IDE submissions to NDA/BLA and medical device applications, we offer individualized support at every stage, providing clarity and focus to your FDA approval path.
COMMITMENT TO YOUR GOALS
We are committed to your product’s success, offering strategic insights and hands-on support to help you meet regulatory milestones and achieve your goals.
How Facet Stands Apart from the Competition
Not all partners deliver the same results. Small life sciences companies deserve a partner that understands their challenges. That is why so many trust Facet Life Sciences to keep their development on track. Here is how we stand apart from other providers.
Facet Life Sciences
- Decades of hands-on regulatory and scientific expertise with proven success supporting 40+ small companies through IND/IDE, NDA/BLA, and device submissions.
- Custom solutions designed for your product, stage of development, and market goals.
- Personalized guidance paired with efficient, low-cost R&D strategies that save time, reduce rework, and support you from pre-IND through post-approval activities.
- Actionable outcomes: prioritized gap list with timelines, costs, and next steps.
Other Life Sciences Consultants
- Limited experience with early-stage innovators and less predictable track record in helping small companies reach key milestones.
- One-size-fits-all approaches that miss nuances in your program.
- Generalized advice with higher overhead, limited alignment to FDA precedents, and little focus on budget-conscious development.
- Broad recommendations without clear roadmaps for implementation.
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