Navigating Regulatory Approval
We are scientists, researchers, and strategists on a mission to help biotech innovators transform their life-changing ideas and breakthrough science into new medical treatments for patients.
Providing a full range of strategic support, from product concept to regulatory interactions to submissions, we help sponsors approach their programs with confidence - minimizing risk and enabling decisions from a position of knowledge and strength.
Quantum Regulatory Consulting provides strategic product development and global regulatory consulting services with unparalleled nonclinical, CMC, quality, clinical, and commercial expertise. We offer end-to-end strategic insights to help biotech companies advance their programs through every development milestone, from the earliest stages through commercialization.
Regulatory Consulting Solutions
Across the development lifecycle, our integrated solutions and cross-functional team provide customized support for your program–from the earliest stages of strategy and planning through FDA approval to commercialization.
Drug Development Strategy
Biotech, MedTech, and small and specialty pharma companies depend on constant vigilance, careful attention to detail, and optimal use of limited resources to realize their products’ life-changing potential. Quantum Regulatory Consulting can help you ascend the challenging path from early discovery through IND application and post-approval life-cycle management.
Whether defining your strategy to achieve FDA buy-in, evaluating the overall appeal of your product concept, prioritizing product opportunities, or assessing a potential investment in an existing asset, we can help guide you throughout the process. Our product development experts, including therapeutic specialists, biostatisticians, and clinical operations professionals, can design a strategy that reduces risk and maximizes the likelihood of commercial success.
Services include:
Product concept evaluation: Starting with a target product profile, we assess the development risks and opportunities to clearly identify your idea’s potential.
U.S. market evaluation: Our experts evaluate your product’s potential by examining current and future competition, unmet needs, marketing requirements, market access considerations, and revenue opportunity, as well as conducting a SWOT analysis.
Business-case insights: We help develop the rationale for asset development or acquisition, including the proposed development outline, potential risks and roadblocks, and valuation.
Product development plan and pre-IND: Look to us for guidance when creating a detailed clinical and development plan, including time- and cost-to-market analysis, FDA feedback, necessary trials, and next steps.
Portfolio analysis: Quantum Regulatory Consulting experts provide a high-level product assessment, product concept analysis, and FDA-vetted development plan to clearly define your path.
Regulatory Services & Support
Quantum Regulatory Consulting offers a full range of regulatory support services, from product concept to submissions to regulatory interactions. Our consultants can extend the reach of your in-house regulatory team or handle it all as your regulatory department — preparing and reviewing documents for submission to regulators, helping to attain expedited development designations, and providing strategic regulatory guidance in preparation for submissions and meetings with global health authorities.
We thoroughly analyze the issues associated with your unique program and assess the regulatory environment, ensuring that you will approach regulators with confidence — minimizing risk and negotiating from a position of knowledge and strength.
Regulatory consulting services include:
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Preparation, submission, and support of pre-investigational new drug (pre-IND) meetings
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Assessment, strategy, and planning services, including gap analysis, risk assessment, and target product profile development
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Request, preparation, and submission for orphan drug designation, rare pediatric disease designation, and qualified infectious disease product designation
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pre-NDA and advisory committee preparation and meetings
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Type A, B and C meeting requests
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Pediatric Study Plans (iPSPs) and Pediatric Investigation Plans (PIPs)
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Safety and post-marketing reporting and support
Medical & Regulatory Writing
Quantum Regulatory Consulting provides medical writing and editing services for a wide variety of regulatory documents, ranging from pre-IND submissions through post-marketing commitments. We have extensive experience supporting both single-document and large-scale submissions across a diverse assortment of indications. Our writers are familiar with regional healthcare authority requirements, ICH and GCP guidelines, and best industry practices, and our documents are prepared in eCTD format.
Quantum Regulatory Consulting’s regulatory medical writing services include:
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Regulatory/health authority submission documents for the FDA and EMA
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Regulatory review – consistency of message, regulatory commitments
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Clinical documents – support for labeling
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Document quality control – data integrity
Regulatory Document Services
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Investigational new drug, new drug application, and market authorization application modules (2.4, 2.5, 2.6, 2.7)
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Investigator brochures
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Development safety update reports
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Regulatory responses
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Integrated summaries of safety and integrated summaries of effectiveness
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Briefing books
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Lay summaries for the European Union
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Health authority meeting materials
Clinical Document Services
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Protocols
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Protocol amendments
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Clinical study reports
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Annual reports
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Narratives
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Executive summaries
Chemistry, Manufacturing, and Controls
Quantum Regulatory Consulting’s regulatory affairs and technical services experts have managed numerous product development and manufacturing programs for small molecules and biologics, which have culminated in the successful submission of CMC dossiers for investigational new drugs, clinical trial applications, biologics license applications, and new drug applications.
Recognizing that early involvement in product development can save you significant time and money, we advise on formulation and design, design and review protocols, and identify the best method validation strategy to ensure compliance with guidelines from the ICH and global regulatory bodies.
CMC components include:
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Drug product development report documentation
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Clinical trial material report documentation
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Supply-chain and manufacturing strategy: Oversight of technology transfers, documentation related to manufacturing strategy and process development/optimization
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Quality and compliance: Including gap and risk assessments, process validation, and quality management system development
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CMC regulatory, technical, and document review: Supporting you at all stages of drug development
Careers
Looking to join a team-oriented, strong, talented, and diverse team? We are passionate about accelerating access to medicines that address global patient needs, enhance quality of care, and improve health outcomes.
Never satisfied with the status quo, we are curious learners who explore the depths of science while always upholding our patient-centric focus.
Enjoy a meaningful, rewarding career in our vibrant culture, where you will contribute to important drug advances and approvals to enhance others' lives. You will gain experience across a variety of therapeutic areas with collaborative, hands-on insights into the development and regulatory process, including direct FDA interactions. We offer competitive packages and great benefits.
JOIN OUR TEAM AND MAKE A DIFFERENCE
Joijn a dynamic, fast-growing business that upholds a culture centered on high performance, is attentive to improving quality of work-life, and offers rewards commensurate with achievement. Come join Quantum Regulatory Consulting!
