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Regulatory Consulting

FDA Approval Consulting Services

At PeploBio, we offer comprehensive regulatory affairs services to help medical device manufacturers obtain FDA approval for their devices. Our experienced team of experts specialiszes in clinical, regulatory, and quality affairs, providing a complete range of services to ensure your device meets all necessary requirements for market approval.

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Steps for FDA Approval Process

By partnering with a CRO specialising in regulatory affairs like PeploBio, medical device manufacturers can navigate the FDA approval process with confidence and efficiency.

  • 1. Effective Regulatory Strategy Development

    Conduct an initial consultation with the manufacturer to understand the product, target market, and regulatory requirements. Develop a regulatory strategy that aligns with the manufacturer’s goals and timelines.

  • 2. Preclinical Testing

    Conduct preclinical testing to evaluate the safety and efficacy of the medical device. Develop a preclinical testing plan that complies with FDA guidelines.

  • 3. Clinical Trial Design and Management

    Design and manage clinical trials that comply with FDA regulations. Develop protocols, case report forms, and informed consent documents. Monitor the trials to ensure compliance and accuracy of data.

  • 4. FDA Submission Preparation and Review

    Prepare the 510(k) submission or premarket approval (PMA) application. Review the submission to ensure compliance with FDA requirements. Manage the communication with the FDA during the review process.

  • 5. Post-market Compliance

    Enable manufacturers to maintain compliance with FDA regulations after approval. Monitor adverse events and report them to the FDA if necessary.

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Regulatory Affairs Services for FDA Approval

We provide a complete range of regulatory affairs services to support your medical device throughout the regulatory process.

  • Regulatory Strategy Development

    Our experts work with you to develop a customiszed regulatory strategy that addresses your specific device and business needs.

  • Regulatory Submissions Preparation and Management

    We prepare and manage all necessary regulatory submissions, including 510(k) and PMA applications, to ensure that your device meets all regulatory requirements.

  • Clinical Trial Planning and Management

    Our experts provide comprehensive clinical trial planning and management services to ensure that your device meets all necessary clinical requirements.

  • Quality System Development and Management

    We assist in the development and management of quality systems, ensuring that your device meets all necessary quality standards.

  • Labelling and Promotional Material Review

    We review all labelling and promotional materials to ensure compliance with FDA regulations.

  • Post-market Surveillance and Reporting

    We provide ongoing post-market surveillance and reporting services to ensure that your device remains compliant with FDA regulations.
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Clinical Performance Evaluations

One of the most important aspects of obtaining FDA approval for a medical device is demonstrating its safety and effectiveness through clinical performance evaluations. Clinical performance evaluations assess the safety and performance of your medical device in a clinical setting and provide valuable data that can be used to support your FDA submission.

Our team has extensive experience in designing and conducting clinical performance evaluations for medical devices. We can help you develop a clinical evaluation plan that meets FDA requirements and guide you through the clinical trial process from start to finish.
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Why PeploBio

Choosing the right regulatory affairs partner is critical to the success of your medical device. At PeploBio, we have a team of experienced regulatory experts who can guide you through the complex regulatory landscape and ensure that your device meets all necessary requirements for market approval. We offer:

  • Comprehensive regulatory affairs services: Our experts specialise in clinical, regulatory, and quality affairs, providing a complete range of services to ensure your device meets all necessary requirements for market approval.

  • Customised regulatory strategies: We work with you to develop a customised regulatory strategy that addresses your specific device and business needs.

  • FDA expertise: Our experts have extensive knowledge of FDA regulations and guidance documents, ensuring that your device meets all necessary requirements.

  • Proven track record: We have a proven track record of success in obtaining FDA approval for medical devices across a wide range of therapeutic areas.

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We are here to answer your questions, discuss potential collaborations, and explore how our our solutions can benefit you.
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UKAS Accredited

PeploBio is a UKAS accredited Medical Laboratory No. 22998. Our UKAS accredited ISO:15189 laboratory has robust quality processes in place, essential for supporting drug and vaccine discovery, validation, and development.

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GDPR-Compliant

We are ICO registered organisation with clearly defined data privacy policies, and robust data protection systems to ensure third party patient data remains protected.

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