Emergency Response to Regulatory Inquiries

Tap our proven, successful approach to responding to cold chain-related regulatory inquiries.

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Emergency Response to Regulatory Inquiries

Regulatory Responses That Keep Your Drug Filing on Track

Good communication is vital to getting your drug product reviewed and approved without delay. And the more novel or advanced your therapy, the greater the odds that regulators will have questions or request more data. When regulators present an Information Request (IR), complete response review letter (CRL), or other inquiry, Modality Solutions can draft a rapid, effective response designed to keep your filing moving forward.

Technical Writing Proven to Satisfy Any Regulatory Inquiry

Modality Solutions is the right partner to help you respond to regulatory inquiries appropriately, reduce potential delays, adhere to accelerated deadlines, and keep your therapy’s review and approval on track. We’ve worked with dozens of drug products on accelerated pathways—including Fast Track, Breakthrough Therapy, Regenerative Medicine Advanced Therapy, Advanced Approval, and Priority Review.

Solid technical writing is a unique craft—one our engineers have perfected through many years of drafting technical assessments for thermal packaging, validation test data technical reports, regulatory responses, SOPs for pack-out and other procedures, operational qualification (OC) and performance qualification (PQ) protocols and data packages, and training documentation. On every emergency response project, we couple our extensive technical writing experience with careful analysis and unmatched knowledge of ever-evolving global cold chain regulations and guidance.

The result: A proven track record of successful responses to regulatory inquiries, for the most advanced therapeutics, on accelerated timelines.

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Our Cold Chain and Technical Writing Expertise Makes the Difference

Our Cold Chain and Technical Writing Expertise Makes the Difference

When a regulatory inquiry threatens to slow your drug product’s filing, you can’t risk a response that’s not complete, effective, and timely. With unrivaled cold chain expertise and technical writing experience, Modality Solutions is uniquely qualified to help you respond to emergency requests in a way that maximizes the odds of a fast, successful filing.

What makes Modality Solutions the right choice for the most effective emergency response to your regulatory inquiries?

  • We leverage our in-depth understanding of cold chain regulations and requirements, gained during 250+ successful regulatory interactions for 125+ approved therapies.
  • Our work has never been rejected by any regulatory agency in the world, at any time.
  • We’re highly agile and able to respond in as little as 24 hours in emergency situations.
  • We support our regulatory responses with robust transport simulation testing data and ASTM/ISTM testing data.
  • We’ve honed our technical writing skills by responding to regulatory agency inquiries, so we know what to expect and how to craft a reply that gets the optimal results.
  • We apply a multidisciplinary approach to helping move your therapeutic through the regulatory review process, drawing on our deep cold chain expertise.

How A Fast IR Response Helped Immunomedics’ ADC Therapy Gain Accelerated Approval

During its BLA filing for TRODELVY™, an antibody-drug conjugate (ADC) therapy for triple negative breast cancer, Immunomedics received several Information Requests (IRs) about its cold chain validation strategy. To respond effectively and keep its accelerated approval planson track, the company turned to Modality Solutions. In just two weeks, our engineers mapped the supply chain, conducted a risk assessment, developed a risk mitigation strategy…

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Solutions that Eliminate Regulatory Inquiry Obstacles

When regulators pose questions or need clarification about your drug filing, Modality Solutions can bring our full range of technical capabilities and engineering solutions to bear.

See which solutions are right for your therapeutic type and your current clinical phase.

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Emergency Response capabilities?

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More Capabilities to Support Your Regulatory Filing

When a pharmaceutical manufacturer or biopharmaceutical company is preparing to file an NDA or BLA, Modality Solutions applies capabilities like these to keep promising new therapeutics advancing through the review and approval process.

More Capabilities to Support Your Regulatory Filing

Cold Chain Engineering

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More Capabilities to Support Your Regulatory Filing

AI-Driven Cold Chain Optimization

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More Capabilities to Support Your Regulatory Filing

Transport Simulation Lab

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