Skip to content
Contact Us
Hybrid outsourcing Hybrid outsourcing

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.
    FSP

  • 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. 
    iStock-1677375088 (1)

  • 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.
    ectd2

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.

  • Explore

    Regulatory Affairs

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

    Biostatistics

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

    Statistical Programming

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

    Medical Writing

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

Read our latest Precision insights

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

Explore our blog
Read: Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

Translational Research - Regulatory - Assays - Gene Therapies

Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

|
    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1736962071401, description=Pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Deb%20Phippard.webp',altText='Deb Phippard',fileId=165892372605}, linkedin=https://www.linkedin.com/in/deb-phippard-103b54, team=[{id=163072475007, name='Precision for Medicine Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1716212769184, hs_created_at=1709645745106, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job= Chief Scientific Officer, slug=deborah-phippard, email=, hs_updated_by_user_id=26433386}, second={hs_id=159488778840, hs_child_table_id=0, hs_updated_at=1716132440837, hs_published_at=1736962071401, description=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, avatar=Image{width=710,height=710,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Maham_Ansari.png',altText='Maham_Ansari',fileId=167373022876}, linkedin=https://www.linkedin.com/in/maham-ansari-ms-rac-6a735739, hs_name=, hs_path=, lastname=Ansari, hs_initial_published_at=1716212769184, hs_created_at=1709645745071, hs_is_edited=false, hs_deleted_at=0, name=Maham, job=, slug=maham-ansari, email=, hs_updated_by_user_id=26433386}, third={}})
  • Deborah P. avatar

    Deborah P.
  • Maham A. avatar

    Maham A.
Discover
Read: What Is an FDA Breakthrough Therapy Designation? What Is an FDA Breakthrough Therapy Designation?

Clinical Trials - Regulatory

What Is an FDA Breakthrough Therapy Designation?

|
    has not third author: true, (SizeLimitingPyMap: {main={hs_id=167363064857, hs_child_table_id=0, hs_updated_at=1719905898183, hs_published_at=1736962071401, description=Industry-leading oncologist and demonstrated medical leader in precision medicine, novel trial design and innovative regulatory initiatives designed to expedite drug approvals. Draws on nearly a decade leading oncology and rare disease programs at the FDA. Former fellow at the National Cancer Institute and frequent featured speaker at ASCO and AACR. CDER technical authority on oncologic drug and biological products for thoracic and head and neck malignancies, neurologic tumors, pediatric solid tumors and rare tumors., avatar=Image{width=553,height=580,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Harpreet-Singh2.png',altText='Harpreet-Singh2',fileId=171747124346}, linkedin=https://www.linkedin.com/in/harpreetsinghmd/, team=[{id=163072475007, name='Precision for Medicine Leadership'}], lastname=Singh, MD, hs_initial_published_at=1715692570942, hs_created_by_user_id=2737751, hs_created_at=1715692477118, hs_is_edited=false, hs_deleted_at=0, name=Harpreet, job=Chief Medical Officer, slug=harpreet-singh, hs_updated_by_user_id=26433386}, second={}, third={}})
  • Harpreet Singh, MD avatar

    Harpreet Singh, MD
Discover
Read: Therapeutic Genome Editing – Reshaping the Landscape of Advanced Therapies Therapeutic Genome Editing

Regulatory - Gene Therapies

Therapeutic Genome Editing – Reshaping the Landscape of Advanced Therapies

|
    has not third author: true, (SizeLimitingPyMap: {main={hs_id=169567234066, hs_child_table_id=0, hs_updated_at=1723217613021, hs_published_at=1736962071401, description=Precision Experts are among the most experienced specialists in clinical research. We focus our hiring strategy on select indications to deliver excellence across each role. , avatar=Image{width=800,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Precision%20Expert.png',altText='Precision Expert',fileId=164175466823}, lastname=Experts, hs_initial_published_at=1718988967067, hs_created_by_user_id=26433386, hs_created_at=1717603871601, hs_is_edited=false, hs_deleted_at=0, name=Precision, slug=precision-experts, hs_updated_by_user_id=26433386}, second={}, third={}})
  • Precision Experts avatar

    Precision Experts
Discover

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.

  • Discover Explore
    clinical-trial-support

    Global CRO
    Services

    Award-winning CRO with deep oncology and rare disease expertise

    Explore
  • Discover Explore
    specialty-lab-services

    Global Laboratory
    Services

    Exceptional translational and biomarker sciences with global central lab services

    Explore
  • Discover Explore
    Manufacturing

    Manufacturing
    Solutions

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

    Explore