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.

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.

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.
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.
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.
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.
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.
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

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.

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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.

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Our partnership with Precision is a true textbook definition of a great collaboration between a sponsor and a CRO.

— Senior Director, Midsize Biotech
I recognize that relations between Sponsors and CRO vendors can be strained and difficult, often a blaming game; this has never been my experience with this group as it truly felt like a partnership.

— Director, Small Biotech
We have been delighted with the experience level and work product from the entire project team – they feel like an extension of our internal team.

— Director, Midsize Pharma
At so many levels, the Precision for Medicine team has been fantastic. I am very grateful for how responsive and how collaborative the whole team is. Very grateful for their help.

— Director, Midsize Biotech

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.

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Translational Research - Regulatory - Assays - Gene Therapies

Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

Jan 07, ‘25 | 11 min read

Deborah P.

Maham A.

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Clinical Trials - Regulatory

What Is an FDA Breakthrough Therapy Designation?

Nov 04, ‘24 | 8 min read

Harpreet Singh, MD

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Regulatory - Gene Therapies

Therapeutic Genome Editing – Reshaping the Landscape of Advanced Therapies

Oct 10, ‘24 | 2 min read

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Specialized capabilities in every stage of clinical development

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