Regulatory Affairs Consultancy for Medical Devices, Cosmetics, and Food Supplements

Your Regulatory Expertise And Compliance Experts

Navigating the complex regulatory landscape is critical for market access and product compliance. At Eomi Consultancy, we offer comprehensive regulatory affairs consultancy services for medical devices, cosmetics, and food supplements, ensuring your products meet the necessary standards and regulations to thrive in global markets

Regulatory Documentation: Ensuring Compliance at Every Step

Essential Elements of Regulatory Documentation

Preparation and Submission

Regulatory documentation requires thorough preparation and accurate submission of essential reports to agencies like the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. This process involves collecting data from clinical trials, lab tests, and manufacturing processes to prove that the product adheres to all applicable regulatory requirements. We ensure every step is handled meticulously to maintain compliance and support a smooth approval process.

Maintenance

After submission, regulatory documentation must be meticulously maintained and kept up-to-date. This includes updating records with any new information, changes in manufacturing processes, or additional safety data. Consistent maintenance ensures that the regulatory files reflect the product’s current status, remaining compliant and easily accessible for inspections or audits.

Document Management

We take care of your regulatory documentation and technical files on an ongoing basis, ensuring that your products stay compliant with the regulations of the markets where they are distributed. Our team tracks submission deadlines, renewal dates, and compliance status to ensure your products meet regulatory standards throughout their entire lifecycle.

Types of Regulatory Documentation

Technical Files

Your technical documentation includes comprehensive details about the product’s design, manufacturing process, and quality control measures. For medical devices, this means the technical file must demonstrate that the device meets all the essential requirements outlined in the applicable regulations, ensuring safety, performance, and compliance.

Clinical trial reports and clinical evaluation play a crucial role in demonstrating a product’s safety and efficacy. Clinical trials provide evidence based on rigorous testing, while clinical evaluation analyzes all available data to assess the overall safety and performance of the product in real-world conditions.

The Declaration of Conformity is an official statement confirming that your product meets all applicable regulations and standards, ensuring it is fit for market distribution.

These include a range of applications and forms submitted to regulatory bodies such as the UK MHRA and the US FDA. Each submission must be meticulously prepared to comply with the format and content requirements specified by the relevant regulatory authorities.

Our involvement doesn’t stop after the product launch. Once a product is on the market, continuous monitoring and reporting of its performance, as well as any adverse events, are critical to ensure ongoing safety, compliance, and product success.

Our Regulatory Affairs Services

Our regulatory affairs consultants provide a range of services tailored to your specific industry and product needs. Whether you’re seeking assistance with documentation, compliance management, or navigating regulatory submissions, we ensure your products meet the requirements of regulatory bodies, including the MHRA, EMA, and other key authorities.

 

Regulatory Documentation Preparation and Submission

Regulatory documentation is crucial for compliance with industry regulations. We handle the preparation and submission of all necessary documents, ensuring accuracy and alignment with UK and EU standards. Our services include:

  • Technical File Preparation
    Creating comprehensive technical files that meet regulatory standards and provide a detailed record of your product’s design, manufacturing, and safety compliance.

  • Clinical Trial and Evaluation Reports
    For medical devices and certain cosmetic products, we assist with the preparation of clinical trial reports, ensuring compliance with clinical evaluation requirements.

  • Declarations of Conformity
    We prepare and submit your Declaration of Conformity, verifying that your products meet the relevant regulatory requirements for market entry.

 

Ongoing Regulatory Compliance Maintenance

Compliance is an ongoing process. We provide services to ensure your products remain in compliance with changing regulations. This includes:

  • Regulatory Updates
    Staying informed about regulatory changes in your industry and ensuring your products comply with any new or updated regulations.

  • Post-Market Surveillance
    We support ongoing post-market surveillance to monitor product safety, effectiveness, and performance after market launch.

Comprehensive Document Management

Our consultancy also offers document management services, helping you organize and maintain essential regulatory documents. We ensure your records are up to date and readily available for inspections or audits.

Why Choose Eomi Consultancy for Regulatory Affairs?

  • Industry Expertise
    With over 15 years of experience in regulatory affairs, we provide expert guidance and tailored services for medical devices, cosmetics, and food supplements, helping you stay ahead of regulatory changes.

  • Customized Solutions
    We understand that every product and business is unique. Our services are customized to fit the specific needs of your product and market, ensuring the best possible regulatory strategy.

  • Comprehensive Service Offering
    From regulatory documentation preparation to ongoing compliance maintenance, Eomi Consultancy offers a one-stop solution for all your regulatory affairs needs, making your market access seamless.

  • Transparent & Cost-Effective
    We provide competitive pricing with no hidden fees, ensuring you get expert support without compromising on quality. Our clients appreciate our transparent approach to costs and services.

  • Global Compliance Assurance
    Whether you’re launching your products in the UK, EU, or beyond, we ensure full compliance with local and international regulations, giving you peace of mind and the ability to focus on growing your business.

  • Ongoing Support & Guidance
    Our consultancy is not just a one-time service provider. We offer ongoing support to ensure your regulatory affairs stay up to date and your products comply with evolving regulations.

Let’s Discuss Your Regulatory Needs