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Navigate Regulatory Affairs with Precision

Your strategic partner in achieving global regulatory success. Contact us
Precision’s Global Regulatory Affairs team combines strategic foresight and operational expertise with a foundation in scientific, medical, and clinical knowledge to accelerate your journey from development to registration and market access.
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Global Regulatory Affairs expertise with local insights

Precision delivers deep strategic insight with operational excellence in regulatory affairs, guiding sponsors through clinical development, registration, and market access. Our approach is characterized by:
  • Global and Regional Leadership: Our team comprises experienced regulatory experts who stay abreast of the latest regulatory changes, safeguarding alignment of your project with current guidelines and best practices.
  • Regulatory Oversight: A structured escalation pathway and integrated expertise ensure your project receives the focused attention it deserves, mitigating risks and streamlining progress.
  • Unified Communication: Precision offers a single point of contact at the project level, enhancing clarity and efficiency in communication and decision-making.

This integrated approach affirms that Precision for Medicine not only provides global reach but does so with the nuanced understanding necessary for navigating diverse regulatory landscapes effectively.

Comprehensive regulatory services tailored to your needs 

In the ever-evolving regulatory landscape, success hinges on strategic insight and operational expertise. Precision for Medicine offers tailored regulatory consulting services and solutions designed to seamlessly integrate with your drug development journey, ensuring not just compliance but strategic advantage. Our suite of services, from program management to pediatric planning, is crafted to guide you through regulatory milestones with precision and foresight. Discover how our dedicated experts can propel your project towards regulatory and commercial success.

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    Streamlined Regulatory Program Oversight

    Precision's regulatory insight offers a strategic partnership, providing input   across your drug development lifecycle. By aligning with your goals and timelines, we navigate complexities to maintain momentum toward milestones. Engage with our experts for a tailored approach that integrates seamlessly with your objectives, delivering operational excellence and strategic foresight.
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    Navigating Expedited Pathways

    Accelerate your journey through regulatory landscapes with Precision’s expertise in expedited programs. From identifying eligibility to submission, our team expertly guides your therapy through Fast Track, Breakthrough Therapy Designation, PRIME and more, optimizing your route to market with strategic precision.
  • Precision FSP Program Support

    Regulatory Authority Meetings

    Master your regulatory meetings with confidence. Precision prepares you for critical discussions with health authorities, offering comprehensive support from meeting requests and briefing package preparation to strategic meeting facilitation, so your objectives can be communicated clearly and chart a path forward.
  • Precision FSP Managed Solutions

    Expert Regulatory Submission Preparation

    Precision transforms the complexity of regulatory submissions into a streamlined process. With meticulous attention to detail, we manage INDs, CTAs, NDAs, BLAs, MAAs , ODDs, PIP/PSP and more, ensuring compliance and timely submissions. Let us navigate the regulatory formatting and compilation of eCTD submissions, so you can focus on innovation.
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    Advancing Orphan Drug Designations

    Unlock the potential of your orphan drug with Precision's strategic guidance. We navigate the orphan designation process, maximizing the benefits of tax credits, user fee waivers and market exclusivity to bring your rare disease therapy to those in need.
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    Strategic Pediatric Regulatory Pathways

    Precision specializes in pediatric planning for regulatory success, confirming your research meets specific requirements for studies involving younger populations. We guide you through the regulatory framework, focusing on strategy, submission, and negotiations with health authorities to align with pediatric study plans and fulfill regulatory obligations.

Empowering IVD/CDx & commercial success

Precision’s specialized teams bridge the divide between regulatory strategy and market success. Our In Vitro Diagnostics (IVD) and Companion Diagnostics (CDx) Regulatory team ensure your products not only meet global regulatory standards but also excel in the competitive marketplace. Similarly, our commercialization division, Precision AQ, provides the necessary foresight and strategies to navigate the complexities of market access, payer engagement, and health economics, paying the way for your product’s success. This holistic model underscores our commitment to turning regulatory achievements into commercial victories.

  • Discover IVD/CDx Regulatory Mastery
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    IVD/CDx Regulatory Mastery

    From global assay testing to comprehensive registrations, Precision's IVD Regulatory Affairs team brings over a century of experience in diagnostics, offering tailored regulatory strategies that ensure your innovations achieve global compliance and success.

    Explore IVD/CDx
  • Discover Your Path to Commercialization

    Your Path to Commercialization

    Seamlessly transition from regulatory approvals to market triumph with Precision AQ. Our commercialization experts guide your product through HEOR preparations, market access strategies,and impactful payer and HCP engagements, setting the stage for your success.

    Explore Commercialization

Regulatory insights from Precision’s experts

Stay ahead with the latest regulatory insights from Precision’s team of experts. Discover valuable perspectives, updates, and strategies to navigate the regulatory environment effectively.

Advance therapeutic breakthroughs with Precision

Explore the breadth of our expertise in therapeutics and modalities as we lead your novel treatments in Oncology, Rare Diseases and beyond, from the groundbreaking idea to clinical realization.

Specialized capabilities in every stage of clinical development

Leverage an integrated infrastructure that reduces the inefficiencies inherent in complex development. Integrate lab and trial execution to increase speed to market. Incorporate manufacturing expertise for advances therapies to ensure scalability. Precision can customize and converge our capabilities for your program's unique needs.

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    Global CRO

    Award-winning CRO with deep oncology and rare disease expertise

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    Global Laboratory

    Exceptional translational and biomarker sciences with global central lab services

  • Manufacturing


    Pioneers in planning, building and maintaining manufacturing at scale for pharma and biotechs.