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Precision eCTD Submission Services: Expediting Time to Market

Submission expertise, superior delivery at the speed of Precision.
For over two decades, Precision for Medicine has engaged in a wide array of submissions spanning various therapeutic areas, product categories, and regulatory bodies worldwide. Our eCTD services are designed to streamline your regulatory submissions, guaranteeing adherence to guidelines while mitigating risks and simplifying complexities encountered throughout the submission process.

Proven track record of successful eCTD submissions

In the rapidly evolving regulatory environment, having a reliable partner is essential. Precision is proud to have facilitated numerous complex submissions, achieving significant regulatory milestones:

125
eCTD submissions annually
100
Submission acceptance rate

Transforming your submission journey, with Precision

Timely and cost-efficient eCTD submissions are supported by thorough submission planning, carried out by proficient multidisciplinary teams, and stringent compliance measures. At Precision, our approach to eCTD submissions aims to comprehend your submission objectives, identify potential gaps, and establish a clear strategy to guarantee high-quality, accelerated submissions.
  • Submission Strategy
  • Interdisciplinary Expertise
  • Agile Delivery
  • Seamless Submission Planning

    At Precision, we recognize the distinctiveness of each submission. Our strategies for submissions adapt to ever-changing guidelines and stringent timelines, all the while prioritizing flawless execution.
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  • Expertise Spanning Multiple Disciplines

    Our fully integrated submission teams across regulatory affairs, biostatistics and medical writing, leverage their collective strengths to help you achieve your submission goals. 
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  • Agile Delivery Models

    Submissions are dynamic and so should be the delivery models. Our ability to adapt to ever-evolving project needs, shifts in timelines, regulations, and program complexities is what truly differentiates us.
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Intersection of regulatory, statistical and medical writing expertise

Every module within eCTD submissions requires unique expertise. Guided by robust program management principles, our multidisciplinary teams across regulatory affairs, biostatistics, statistical programming and medical writing collaborate seamlessly through the submission journey.

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    Regulatory Affairs

    Regulatory experts with decades of experience supporting complex global and regional submissions.
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    Regulatory Affairs

    Regulatory experts with decades of experience supporting complex global and regional submissions.
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    Biostatistics

    Meticulous integration of diverse clinical data for simplified analysis, insight generation, and reporting.
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    Biostatistics

    Meticulous integration of diverse clinical data for simplified analysis, insight generation, and reporting.
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    Statistical Programming

    Harmonization and integration of CDISC-compliant data across studies to produce submission-ready outcomes.
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    Statistical Programming

    Harmonization and integration of CDISC-compliant data across studies to produce submission-ready outcomes.
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    Medical Writing

    Experienced medical writing team with advanced scientific knowledge, and proficiency in submission processes.
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    Medical Writing

    Experienced medical writing team with advanced scientific knowledge, and proficiency in submission processes.
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Read our latest Precision insights

Stay updated with the latest insights in eCTD publishing and submission through our blog. 

Read: What the EMA–FDA AI Principles Really Mean for Clinical Development & Regulatory Affairs What the EMA–FDA AI Principles Really Mean for Clinical Development & Regulatory Affairs

Clinical Trials - Regulatory

What the EMA–FDA AI Principles Really Mean for Clinical Development & Regulatory Affairs

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  • John M. avatar Nicholas R. avatar Rosamund R. avatar
  • John M.

    Nicholas R.

    Rosamund R.

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Read: EMA PRIME Scheme Explained: Eligibility, Benefits, Risks, and When to Apply EMA PRIME Scheme Explained: Eligibility, Benefits, Risks, and When to Apply

Clinical Trials - Regulatory

EMA PRIME Scheme Explained: Eligibility, Benefits, Risks, and When to Apply

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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=1772549698856, 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=26433386}, second={hs_id=159488778852, hs_child_table_id=0, hs_updated_at=1765558855468, hs_published_at=1772549698856, description=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., avatar=Image{width=1200,height=1200,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Chris-Ingram.png',altText='Chris-Ingram',fileId=202456722303}, linkedin=https://www.linkedin.com/in/chris-ingram-0255b216, hs_name=, hs_path=, lastname=Ingram, hs_initial_published_at=1772549698923, hs_created_at=1709645745083, hs_is_edited=false, hs_deleted_at=0, name=Chris, job=Executive Director, Regulatory Affairs, Europe, slug=chris-ingram, email=, hs_updated_by_user_id=26433386}, third={}})
  • John M. avatar

    John M.

  • Chris I. avatar

    Chris I.

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Clinical Trials - Regulatory

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  • John McIntyre, PhD avatar

    John McIntyre, PhD

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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 accelerate speed to market. Precision can customize and converge our capabilities to meet your program's unique needs—driving efficiency, agility, and success from start to finish.

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    Award-winning CRO with deep oncology and rare disease expertise

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    Exceptional translational and biomarker sciences with global central lab services

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