Gap Analysis and Risk Assessment

CMC HealthChek™ – Program Gap Analysis

Pharmaceutical development is fraught with challenges due to complex regulatory requirements and increased inspections from health authorities. We help you with proven gap analysis that accelerates compliance and fast-tracks your time to market.

A Comprehensive Solution for Quality And Compliance

DSI CMC HealthChek™ is designed as a solution for sponsors concerned with creating development and compliance strategies for their projects' next milestones. We provide a comprehensive gap analysis and risk assessment of the entire project presented in an eCTD format.  By using this format, we are able to show a sponsor’s potential obstacles to their next authoring milestone.

If the next milestone is not submission-driven, it can be amended to cater to the development lifecycle (DS, DP, and Quality Systems) so you can proactively address issues before they become a compliance or process concern.

We review and evaluate for accuracy all accessible and pertinent information and documentation from labs, vendors, and manufacturing sites, reports, and agency correspondence. We then identify missing data and documents that are not available but required for a phase-appropriate asset.

CMC HealthChek™ review is done based on the documents submitted to DSI by clients electronically. The gap analysis reports are subject to the availability and adequacy of the source documents (for example, manufacturing records, development reports, and other available data) needed for each module.

Remediation Strategies

The gap analysis process it intends to unearth discrepancies in information or process and eliminate the risk of penalties and product recalls.

You get a summarized report of your CMC program gaps that highlight any identified minor, major or critical shortcomings. We further provide feasible remediation approaches in these reports, allowing you to mitigate risks on time to keep drug programs on track.

In the process, we advise on design and formulation, site inspection and monitoring, and design/review protocols. We identify the best validation strategies to streamline compliance with FDA and ICH guidelines.

Why Do the CMC HealthChek™?

CMC is under consistent scrutiny due to stringent compliance requirements, increasing regulatory workloads, and increasing health inspections from the authorities. Partnering with us helps you undertake resource-intensive analyses to identify risks and issues before you face product recall and reputation damage.

CMC HealthChek™ is a real-time gap inspection approach that enhances compliance without you having to divert internal resources or stall development.

Benefits of the DSI Gap Analysis:

  • Assesses and determines whether CMC development efficiently addresses product safety, quality, and efficacy.
  • Identifies any current CMC issues that exist before IND reports, EOP2 meetings and NDA/CTD, and the inception of clinical trials in the US and EU.
  • Establishes a benchmark and strategy for new in-licenses
  • Feedback to improve productivity, faster release, and decrease costs

DSI Expertise

Our excellence is driven by a multidisciplinary team of development, manufacturing, control, and regulatory affairs professionals. This expansive field-tested experience makes CMC HealthChek™ your single reliable source for proactive problem-solving in CMC lifecycle management.

We bring broad product development expertise and commercialization experience across small molecule and biologic stages. We consolidate our top-down expertise and knowledge with risk-based submission writing and compliance strategies for all development phases and dosage forms.

Unlike other compliance solutions that require a significant investment of time and money, DSI CMC HealthChek™ is driven by best practices and innovation that accelerates the process and reduces costs. By empowering innovation to drive management and insight, CMC HealthChek™ sets you up for success through adherence to regulatory requirements and continuous process optimizations throughout the pharmaceutical development lifecycle.

Our timely involvement in the development process can save you significant time and money. DSI offers strategic guidance and compliance support from molecule discovery to the final product. Let’s talk.

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