Regulatory / Commercialization

Our team of regulatory experts has first-hand experience working at the FDA as well as in the pharmaceutical and diagnostic industries developing products regulated by the FDA. We believe that successful product development is based on carefully planning ahead and identifying and choosing the right regulatory tools for productive interactions with regulatory authorities. We can help you addressing these needs for individual products as well as create comprehensive strategies for entire portfolios.
Our believe is that creating a successful product starts with the definition of its market and realistic assessment of the product’s potential impact on the market. Discerning market dynamics and crafting ideas for product positioning should be part of initial product development considerations. Thinking ahead leads to more focused decisions. We can help you research markets, design market access strategies, e.g. via key stakeholders and KOLs for early access programs, and identify other opportunities that will lead to a successful launch.

Representative Services

  • Regulatory strategy and competitive intelligence for specific products, research fields, or therapeutic areas
  • Identification of regulatory pathways for drugs and diagnostics, including companion diagnostics
  • Planning of interactions with regulatory authorities
  • Preparation, writing and/or review of regulatory documentation and submissions
  • Regulatory representation

Typical Challenges we Encounter in Regulatory/Commercialization

  • How is the FDA regulatory landscape for X evolving? How does X compare to Y from a regulatory point of view?
  • How does the FDA regulate algorithms and algorithm-based tools that help select the right therapy?
  • Which regulatory pathway is appropriate to accelerate my product development (e.g. breakthrough dedication, voluntary submission, pre-Subs, and others)? How do I apply for it?
  • Will a genetic test be required for approval, under what circumstances, and what are the consequences?
  • How can I align the development of a diagnostic with my drug development so that they are strategically aligned and regulatory submissions for both the drug and the diagnostic are coordinated?
  • Which Center at the FDA should I address for companion diagnostic development information?
  • How does the FDA regulate next-generations sequencing (NGS)-based products?
  • Regulatory strategy and competitive intelligence for specific products, research fields, or therapeutic areas
  • Identification of regulatory pathways for drugs and diagnostics, including companion diagnostics
  • Planning of interactions with regulatory authorities
  • Preparation, writing and/or review of regulatory documentation and submissions
  • Regulatory representation
  • Does my pivotal trial, designed for regulatory purposes also provide useful information for payers? If not, how can I integrate/generate data that is of interest to payers?
  • Is a health economic and outcomes research (HEOR) study needed to convince payers about the value of the product? How should this study be designed and where can it be conducted?
  • What is in the pipeline for indication X? Can I competitively position my product, e.g. using a biomarker?
  • Will reimbursement of the companion diagnostic test automatically follow reimbursement of the drug? Is it advisable to develop a companion diagnostic and what are potential other options?
  • Creating value proposition relevant for payers
  • Design of health economics and outcomes-based research projects
  • Identification of real-world, payer focused research sites and opportunities
  • Evaluation of reimbursement environment

Examples of Completed Assignments

  • Pre-concept regulatory strategy for new diagnostic for sepsis through regulatory approval of product
  • Creation of “own predicate” for product pipeline evolution
  • Regulatory strategy for oncology drug development requiring companion diagnostic
  • Support of (pre-)IDE submission and representation of diagnostic company at FDA
  • Analysis of US reimbursement opportunities for Crohn’s Disease, NASH and NAFLD diagnostics
  • Health economic evaluation and payer strategy of novel renal therapy
  • Identification of market access strategy for new diagnostic via integrated health systems
  • Product positioning for new microbiome company
  • Population-based screening for pharmacogenetic applications, integration into national health care

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