Meeting Pharmaceutical Regulatory Challenges

Occasionally, regulatory agency review of a submission results in requirements for supplementary data (technical, nonclinical, or clinical), re-analysis of existing development data, or confirmation of information. These can delay clearances to complete clinical studies or marketing approval clearances or approvals.

DS InPharmatics (DSI) is an expert in all areas of healthcare product development and testing and can cooperate with sponsors to develop responses to regulatory challenges or to conduct programs required to gather information to address data gaps. They can:

  • Give advice about regulatory choices and possible pathways
  • Give responses to Complete response letters (CRL) or clinical holds

Remediation strategy and execution

Adversarial relationships with regulators do not have any positive outcomes, and DSI has helped several companies settle disagreements with agencies by confirming the design and/or interpretation of results in addition to misconceptions implicit parties may have.

In the unfortunate case that the FDA returns a contrary opinion and/or non-approval, DSI can skillfully assess the technical and scientific details of FDA conclusions. DSI participates in a reliable procedure to find problems and remediation strategies. DSI boasts a proficient team, for instance, success when transitioning programs off clinical hold for the submission and filing of NDAs, and then addressing challenges thereafter.

  • Content review questions
  • Clinical holds
  • 505(b)(2) NDA non-approval/refuse-to-file
  • Scientific dispute resolution

FDA chemistry, production and controls challenges

With success nearing, the last step is an Agency agreement on the clinical and/or commercial supply chain and a high-quality and efficient meeting strategy is required. DSI has established a unique technical method for CMC consultations with the Agency to guide businesses through an interaction with a lot at stake. Each program varies and has precise needs and concerns, which must be kept in mind as discussions begin about a business’s product.

A business must learn about core issues in a product’s history and identify critical issues in the current application. After, DSI can create a strategy suitable for a consultation that is predicated on concerns expected to be brought up by the Agency Reviewers, and the data needed to address them.

With this strategy in place, DSI can help businesses to prepare a slide presentation that offers all information in a complete, comprehensible, and simple manner. The majority of FDA reviewers will assess this information prior to the meeting, so it is a good idea to make it easy for them to understand why approval is rational. Next, it is important that all participants are prepared for the meeting by completing a rehearsal to train speakers. DSI will conduct this, as well as attending the meeting with businesses, along with select Subject Matter Experts (SMEs), producing data and presentations, as required during the meeting.

About DS InPharmatics LLC

DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.

Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.


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Last updated: May 8, 2020 at 4:28 AM

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