Navigate regulatory submissions with confidence

Get expertly crafted FDA documentation to streamline your path to compliance, saving you time and resources.

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    Regulatory submissions don’t have to be overwhelming

    Navigating the complexities of FDA and other regulatory submissions requires deep expertise and a structured approach. With our experienced technical writers, your organization gains the regulatory insight and documentation precision needed to meet compliance standards, reduce errors, and accelerate timelines—allowing your team to stay focused on what matters most.

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    Regulatory-focused documentation

    Specialized writers skilled in submissions, including 510(k), ANDA, BLA, IDE, IND, NDA, PMA, and more, ensure your documentation aligns with stringent regulatory guidelines.

    Deep industry expertise

    From healthcare to medical devices and biotechnology, our team understands the regulatory requirements of your field and brings focused expertise to your submissions.

    Your government & regulatory writing consultants

    Whether it's securing funding, achieving compliance, or enhancing communication, we're committed to providing deliverables that empower our clients to succeed.

    Eliminating documentation bottlenecks
    Navigating complex regulatory requirements without experienced support can slow down approvals, increase costs, and drain valuable resources. We provide a structured, standardized documentation approach that ensures consistency and meets compliance standards, accelerating your timeline to approval.
    Providing specialized regulatory knowledge
    Submissions for FDA and other regulatory bodies are rigorous, and lacking regulatory experience can put approval at risk. Our team specializes in regulatory submissions, with in-depth knowledge of healthcare, medical device, and biotech sectors, helping you avoid unnecessary errors and resubmissions.
    Delivering end-to-end support
    Managing the full submission process requires precision, attention to detail, and dedicated focus. We handle every step, from initial drafts to the final review, freeing up your team to focus on core operations. Our structured approach minimizes delays and costly errors, providing a clear path to compliance.

    “Working with DevDocs is incredibly straightforward due to their deep technical expertise and seamless integration of AI into their workflows. This not only enhances the quality of their documentation but also significantly accelerates production times.”

    Logan Lawler, AI Workstation GTM/Solutions/Alliances

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    “DevDocs is the ideal tech partner for our fast-paced environment. They consistently deliver excellent solutions quickly, and have successfully handled every challenge we’ve presented to them, from blog writing to web development.”

    Ryan Young, Technical Writing Strategist

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    "DevDocs improved the readability of our existing content and corrected misleading instructions, preparing our services for Beta release seamlessly. Their attention to detail was impeccable. Moreover, DevDocs went above and beyond by creating user content for unreleased features, ensuring our clients continue to derive value in the future."

    Marc LeDoux, Full Stack Developer

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    “Their expertise in web development, content creation, and blockchain integration allowed us to complete a complicated and multifaceted project swiftly and seamlessly, with the DevDocs team managing every aspect of the project in a professional and timely manner.”

    Brendon Pasisi, Project Manager

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    Helping a medical device win FDA approval

    When medical device manufacturer Pulsario needed structured, FDA-compliant processes and documentation, the startup turned to DevDocs for support in streamlining submissions and ensuring regulatory success.

    Efficient, standardized documentation process

    Through standardized templates and clear, organized processes, DevDocs helped Pulsario achieve high-quality documentation that met compliance standards across all project stages. This structured approach allowed Pulsario to manage the complexity of documentation demands with greater ease and consistency, optimizing efficiency from start to finish.

    Enhanced workflow through agile development

    Pulsario needed to improve their documentation workflow to enhance efficiency and quality. By implementing agile methodologies, DevDocs helped identify new workflows for testing and documentation management, enabling Pulsario to streamline  processes and increase operational effectiveness—an essential step in the journey to compliance.

    FDA regulatory submission expertise

    When Pulsario faced the complexities of creating government-approved documentation, they turned to DevDocs. With our in-depth understanding of industry standards and compliance requirements, we provided the regulatory expertise necessary to navigate the FDA submission process effectively, ensuring a successful outcome for their product launch.

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    Get a project proposal

    A real human being will reach out to tell you exactly what we'd do, how much we'd charge, and why we're the best technical partner for your team's needs.

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