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Beyond Geography: A Former Regulator’s Perspective on Multiregional Oncology Trials

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Regulatory Consulting Services that
De-Risk Development

Integrated strategy and submission support for therapeutics, traditional IVD and companion diagnostics

Make confident regulatory decisions early with a robust strategy that links your evidence plan to the regulatory pathway. Our team of former FDA leaders and global regulatory experts delivers end‑to‑end support from pre‑IND through pivotal registration across investigational product and device pathways, including traditional IVDs and companion diagnostics for biomarker‑selected indications.

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Regulatory Affairs Services and Submission Support

Maintain momentum through development, registration, and market access with global regulatory affairs services that combine strategic insight with operational execution. Whether you are advancing a therapeutic program, building a traditional IVD or a companion diagnostic strategy, our team of experts can support you to align evidence, documentation, and agency interactions across regions and timelines.

23 FDA & EMA approvals in the last 10 years
125 eCTD submissions annually
200 IVD and CDx Presubmissions, IDEs, ITAs, and Annex XIV Submissions
250 510(k), Special 510(k)s, EUAs, De novos, PMAs, PMA supplements for IVD and CDx submissions in the US

Full Lifecycle Regulatory Affairs Services

Advance your program with strategic regulatory guidance that’s fully aligned with clinical operations and lab execution to accelerate approvals for therapeutics, diagnostics, and CDx.
  • Global regulatory affairs
    Explore Global regulatory affairs

    New Drugs & Therapeutics

    • IND/CTA strategy and execution across North America, Europe, Asia Pacific and Latin America
    • Study start-up, IRB/IEC coordination
    • Regulatory agency interactions & scientific advice
    • Expedited, breakthrough and special designations
    • ATMP/Cell & Gene/GMO pathways

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  • eCTD submission services
    Explore eCTD submission services

    Clinical Trials & eCTD Submissions

    • End-to-end eCTD support, IND through NDA and post-approval lifecycle management
    • eCTD publishing and submission operations built to streamline and expedite regulatory submissions
    • Integrated delivery teams across regulatory affairs, biostatistics, and medical writing
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  • IVD consulting
    Explore Companion diagnostics

    Traditional IVDs

    • Regulatory strategy and pathway planning for traditional IVD programs
    • Evidence planning aligned to intended use, claims, and risk classification, including IVDR and CE-mark readiness, where applicable
    • Submission execution support across key global markets 
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  • Companion diagnostics development
    Explore Companion diagnostics

    Companion Diagnostics (CDx)

    • CDx strategy supporting parallel therapeutic development and approvals
    • Assay development and validation across major biomarker methodologies
    • Development roadmap including milestones, timelines and clinical trial enabling submissions including SRD, IDE, Annex XIV
    • Regulatory pathway and timeline planning from trial assay use through commercial readiness
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  • Gene therapy regulatory services
    Explore Gene therapy regulatory services

    IVD Regulatory Services in Gene Therapy CDx

    • Regulatory strategy tailored to evolving expectations for advanced therapies
    • Leading regulatory compliance through product lifecycle for CDx in drug-device co-development programs
    • Guiding the regulatory submission process and agency interactions
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  • Meet Our Regulatory Experts

    Our team includes former FDA leaders, global regulatory specialists, and dedicated diagnostics experts with 100+ years of cumulative industry experience across complex submissions and approvals, traditional IVDs, companion diagnostics (software and hardware), and specimen collection devices.

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  • Nicholas Richardson

    Nicholas Richardson, DO, MPH

    Vice President, Clinical Development & Former FDA Deputy Director

  • Kennon Daniels

    Kennon Daniels, PhD

    Vice President, IVD Regulatory Consulting,

  • Chris-Ingram

    Chris Ingram

    Executive Director, Regulatory Affairs, Europe

  • John McIntyre

    John McIntyre, PhD

    Senior Director, Regulatory Strategy

  • Margaret Curnutte

    Margaret Curnutte, PhD

    Senior Director, IVD Regulatory Consulting

  • Jo-Ann Gonzales

    Jo-Ann Gonzales

    Senior Director, IVD Regulatory Consulting

  • Erica Sablan

    Erica Sablan

    Senior Director, IVD Regulatory Consulting

  • Maham_Ansari

    Maham Ansari

    Senior Director, IVD Regulatory Affairs, Gene Therapy CDx,

  • Sherma Winston

    Sherma Winston

    Senior Director, IVD Regulatory Consulting

Why Precision for Regulatory Affairs Services?

Regulatory needs differ by program type. Choose the path that matches your workstream, therapeutics, traditional IVD, or drug-linked CDx, and we’ll align evidence, agency engagement, and submissions across regions through commercialization and lifecycle change.

 

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  • Therapeutics & Clinical Trials

    Therapeutics & Clinical Trials

    Expert regulatory affairs support across the full product lifecycle

    • IND/CTA enablement and lifecycle maintenance submissions aligned to trial timelines
    • Health authority meeting strategy and briefing package development
    • End-to-end eCTD publishing and submission support

  • Traditional IVD

    Traditional IVD

    Standalone diagnostics including IVDR readiness, evidence, and pathways

    • Intended use/claims/risk-class strategy and global pathway mapping
    • IVDR-compliant assay evidence packages including performance evaluation planning and technical documentation support (where applicable)
    • Trial-enabling submissions and agency/Notified Body interactions (as applicable)

  • Companion Diagnostics (CDx)

    Companion Diagnostics (CDx)

    Accelerate drug-linked diagnostic co-development and approvals

    • CDx co-development regulatory strategy and parallel approval planning
    • Evidence and submission readiness from trial assay use through commercialization
    • Cross-functional coordination for agency interactions and lifecycle change 

Regulatory Affairs Resources and Guidance

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  • Brochure

    IVD Regulatory Consulting

    Download Brochure
    IVD Regulatory Consulting
  • Webinar

    Gene Therapy Assays: Achieving Regulatory Compliance with a Unified Immunogenicity Strategy

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    Gene Therapy Assays: Achieving Regulatory Compliance with a Unified Immunogenicity Strategy
  • Whitepaper

    Beyond Geography: A Former Regulator’s Perspective on Multiregional Oncology Trials

    Download Whitepaper
    Beyond Geography: A Former Regulator’s Perspective on Multiregional Oncology Trials

Insights from the Precision Blog

More From Our Experts
Read: FDA Draft Guidance on Overall Survival in Oncology Trials – What Sponsors Need to Know FDA Draft Guidance on Overall Survival in Oncology Trials – What Sponsors Need to Know

Clinical Trials - Regulatory - Oncology

FDA Draft Guidance on Overall Survival in Oncology Trials – What Sponsors Need to Know

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=195804116748, hs_child_table_id=0, hs_updated_at=1764696930757, hs_published_at=1770979785042, description=John is an experienced regulatory affairs consultant with more than 15 years of professional experience in drug development. He brings a proven track record in providing regulatory strategy, regulatory document development and review, and liaising with regulatory authorities., avatar=Image{width=276,height=290,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/John%20McIntyre.png',altText='John McIntyre',fileId=201584594055}, lastname=McIntyre, PhD, hs_initial_published_at=1757516163742, hs_created_by_user_id=26433386, hs_created_at=1757515873736, hs_is_edited=false, hs_deleted_at=0, name=John, job=Senior Director, Regulatory Strategy, slug=john-mcintyre, hs_updated_by_user_id=65160865}, second={hs_id=195804116749, hs_child_table_id=0, hs_updated_at=1757598950007, hs_published_at=1770979785042, description=An expert in hematology and oncology and a veteran of the FDA with almost nine years of experience, culminating as a Deputy Director for the Division of Hematologic Malignancies 2. Possesses a profound understanding of regulatory strategy, particularly in the development of CAR-T cell therapies, bispecifics and T-cell engagers. Spearheaded initiatives to develop novel endpoints in blood cancer such as minimal residual disease (MRD) in lymphoma and chronic lymphocytic leukemia (CLL.), avatar=Image{width=1000,height=1000,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Nick%20Richardson.jpg',altText='Nick Richardson',fileId=195807970451}, linkedin=https://www.linkedin.com/in/nicholas-richardson-do-mph-049784113/, lastname=Richardson, DO, MPH, hs_initial_published_at=1757516163742, hs_created_by_user_id=26433386, hs_created_at=1757516077087, hs_is_edited=false, hs_deleted_at=0, name=Nick, job=Vice President, Clinical Development, slug=nick-richardson, hs_updated_by_user_id=65160865}, third={}})
  • John M. avatar

    John M.
  • Nick R. avatar

    Nick R.
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Read: Companion Diagnostics: Key Considerations for Registrational Studies and Effective Co-Development with Therapeutics Companion Diagnostics

Translational Research - Regulatory

Companion Diagnostics: Key Considerations for Registrational Studies and Effective Co-Development with Therapeutics

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  • Kennon D. avatar

    Kennon D.
  • Margaret C. avatar

    Margaret C.
Discover
Read: 8 Best Practices for Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy

Translational Research - Regulatory - Gene Therapies

8 Best Practices for Immunogenicity Assay and Companion Diagnostic Development in AAV Gene Therapy

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  • Deborah P. avatar Kennon D. avatar Travis H. avatar

  • Deborah P.

    Kennon D.

    Travis H.
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Specialized Capabilities for Every Stage

Leverage an integrated lab and trial execution infrastructure that reduces the inefficiencies inherent in complex development to accelerate your program's speed to market.

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Nicholas Richardson
Nicholas Richardson, DO, MPH

Vice President, Clinical Development & Former FDA Deputy Director

An expert in hematology and oncology and a veteran of the FDA with almost nine years of experience, culminating as a Deputy Director for the Division of Hematologic Malignancies 2. Possesses a profound understanding of regulatory strategy, particularly in the development of CAR-T cell therapies, bispecifics and T-cell engagers. Spearheaded initiatives to develop novel endpoints in blood cancer such as minimal residual disease (MRD) in lymphoma and chronic lymphocytic leukemia (CLL.)
Kennon Daniels
Kennon Daniels, PhD

Vice President, IVD Regulatory Consulting,

Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms.
Chris-Ingram
Chris Ingram

Executive Director, Regulatory Affairs, Europe

Chris Ingram, BSc (Hons) is Head of Regulatory Consultancy (Europe) for Precision for Medicine. Chris received his BSc(Hons) in immunology and pharmacology from the University of Strathclyde and has since spent over 21 years working in regulatory affairs with a focus on clinical development. Chris’ regulatory expertise covers clinical development across all phases, regulatory strategy, marketing authorisations, scientific advice, orphan drug designation and paediatric investigation plans across a wide variety of therapeutic areas, including but not limited to, oncology, CNS, metabolic, endocrinology, analgesia and cardiovascular.
John McIntyre
John McIntyre, PhD

Senior Director, Regulatory Strategy

John is an experienced regulatory affairs consultant with more than 15 years of professional experience in drug development. He brings a proven track record in providing regulatory strategy, regulatory document development and review, and liaising with regulatory authorities.
Margaret Curnutte
Margaret Curnutte, PhD

Senior Director, IVD Regulatory Consulting

Margaret Curnutte is a Senior Director of Regulatory Affairs within Precision for Medicine’s Translational and Regulatory Sciences Practice, with over ten years of experience across research, regulatory policy, and U.S. and major-market regulatory affairs focused on in vitro diagnostics. She has held regulatory roles in both device and pharmaceutical organizations and has led seven U.S. and ex-U.S. companion diagnostic registrations. Her expertise spans CDx development and clinical trial integration, IVD and next-generation sequencing product development, translation of U.S. regulatory strategy to global markets, and leadership of regulatory submissions including Pre-Submissions, IDEs, SRDs, and PMAs.

Jo-Ann Gonzales
Jo-Ann Gonzales

Senior Director, IVD Regulatory Consulting

Jo-Ann Gonzales, RAC, is a Senior Director of IVD Regulatory Consulting within Precision for Medicine’s Translational and Regulatory Sciences Practice, bringing more than 25 years of U.S. and international regulatory affairs experience. She has deep expertise across the full IVD development lifecycle, including next-generation sequencing and companion diagnostics, with a focus on regulatory strategy and submissions for a wide range of assays such as non-invasive prenatal testing, infectious disease donor screening, oncology, and respiratory viral diagnostics. Her experience includes FDA Emergency Use Authorization (EUA) submissions for SARS-CoV-2 tests, Pre-Submissions, IDEs, De Novo, PMA, and 510(k) applications, as well as review of labeling, advertising and promotional materials, analytical and clinical study design, and use of FDA eSTAR templates. She is also well-versed in regulatory considerations for instrument platforms and software components.
Erica Sablan
Erica Sablan

Senior Director, IVD Regulatory Consulting

As Senior Director of IVD Regulatory Consulting at Precision, Erica brings over 30 years of experience supporting the development of in vitro diagnostics, including molecular diagnostics, next-generation sequencing, and companion diagnostics. Her expertise spans the full IVD lifecycle—from RUO to IVD and DTC genetic testing—and includes analytical and clinical study design, U.S. FDA submissions (Q-Submissions, IDEs, De Novo, 510(k), PMA, and BLA), and EU IVDR CE-IVD registrations and Annex XIV performance study submissions. She has supported both startups and global diagnostic organizations and regularly serves as the client representative in FDA and EU Notified Body interactions.
Maham_Ansari
Maham Ansari

Senior Director, IVD Regulatory Affairs, Gene Therapy CDx,

Maham Ansari, MS, RAC is a Senior Director, IVD Regulatory Affairs. Her focus is on companion diagnostic co-development programs, where she leverages her regulatory expertise to secure approvals in the US, Europe and beyond for companion diagnostics with a specific focus on gene therapy. She brings more than 16 years of global regulatory leadership experience in the medical device and in vitro diagnostics industry, spanning major multinationals to small start-ups, including full life cycle management across all stages of product development, execution of global regulatory strategies, and post-market surveillance.sh
Sherma Winston
Sherma Winston

Senior Director, IVD Regulatory Consulting

Sherma Winston, MSc, RAC, is a Senior Director of IVD Regulatory Consulting within Precision for Medicine’s Translational and Regulatory Sciences Practice, with 14 years of experience supporting in vitro diagnostic development across U.S. and EU markets. Her expertise spans molecular diagnostics and NAATs, regulatory strategy from RUO to CTA to IVD, and marketing submissions for infectious disease, COVID-19, STI, and respiratory assays. She has led analytical validation strategies and regulatory submissions including Q-Submissions, EUAs, 510(k)s, Breakthrough Device designations, PMAs, and IVDR CE marking activities, and regularly serves as the client representative in FDA and EU Notified Body interactions.