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FDA Veteran Paz Vellanki, MD, joins Precision to become one of 3 ex-FDA oncology leaders supporting clients

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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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    Hero_Stats programming

    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. 

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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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    Global CRO
    Services

    Award-winning CRO with deep oncology and rare disease expertise

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    Global Laboratory
    Services

    Exceptional translational and biomarker sciences with global central lab services

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