Expert Regulatory Solutions, Tailored to Your Needs
How We Support Your Compliance Journey
Simplifying Compliance, Empowering Success
At Eomi Consultancy, we guide businesses through the complexities of regulatory compliance for medical devices, cosmetics, and food supplements.
Our team is well-versed in the ever-evolving regulatory landscape, staying ahead of changes so you don’t have to. Whether you’re a start-up or an established brand, we provide tailored solutions to meet your specific needs. More than just consultants, we’re your dedicated regulatory partners, leveraging our industry knowledge to transform complex regulations into actionable strategies.
We speak the language of compliance—ensuring your business stays on track.
Our Tailored Solutions for Seamless Compliance
REGULATORY STRATEGY
When launching new products, every stage of the cycle matters. At Eomi Consultancy, we offer a comprehensive regulatory strategy that guides you through each phase of the product lifecycle. From the initial assessments to final approvals, we ensure that your medical devices, cosmetics, or food supplements meet all required compliance standards, making the process smoother and more efficient.
TECHNICAL FILE REVIEWS
Our technical file creation and review services ensure that your documents meet all the necessary regulatory requirements based on your product’s classification. Whether you’re working with medical devices, cosmetics, food supplements, or other regulated products, we tailor each technical file to align with the relevant standards.
- Medical Devices: We support the creation and review of technical files in compliance with UK MDR 2002, EU MDR, ensuring your devices meet safety, performance, and regulatory requirements.
- Cosmetics: Our services include the preparation of Product Information Files (PIF), ensuring full compliance with the EU Cosmetics Regulation and UK Cosmetics Regulation.
- Food Supplements: We assist in the creation of Food Supplement Dossiers, ensuring compliance with regulatory requirements in the UK and EU, covering everything from product formulation to labeling.
EU AUTHORISED REPRESENTATIVE
Hiring an EU Authorised Representative is essential for non-EU manufacturers to ensure that all required documentation, including the EU Declaration of Conformity and technical files, is accurately prepared and continuously updated, meeting all regulatory requirements for market access.
UK RESPONSIBLE PERSON
Our UKRP Services ensure that your business remains fully compliant with UK regulations. Our team of experts will guide you through each step, helping you understand and implement the necessary measures to meet all relevant UK regulatory requirements with confidence.
FORMULATION REVIEWS
Ensuring that your formulation complies with legislation is crucial for maintaining both safety and efficacy. We carefully evaluate each formulation according to your product’s classification and, when needed, offer alternative solutions to ensure full compliance with regulatory standards.
CLAIMS REVIEWS
Accurate and compliant marketing claims are vital for protecting your brand and avoiding regulatory challenges. At Eomi Consultancy, we thoroughly review all marketing claims—whether on product packaging, websites, or social media—ensuring they align with the relevant regulations and maintain your business’s integrity.
CLAIMS REVIEWS
Accurate and compliant marketing claims are essential for safeguarding brand integrity and preventing regulatory complications. At Eomi Consultancy, we carefully assess all marketing claims—whether on product packaging, websites, or social media—to ensure they comply with the relevant regulations and protect your business from potential risks.
PRODUCT REGISTRATION
Regulatory consultancy is not just a formality; it’s a strategic advantage when you’re ready to enter the market. At Eomi Consultancy, we conduct thorough assessments and manage the entire registration process, ensuring that your products meet all legal requirements for market access.
Want to find out more?
Contact us today to discover how Eomi Consultancy can guide you toward achieving regulatory compliance and ensuring your success in the market.
Who We Help
MEDICAL DEVICES
Eomi Consultancy provides UK Responsible Person (UKRP) services services to help ensure full compliance with UK MDR 2002. As per MHRA requirements, manufacturers outside the UK must designate a UKRP before their products can enter the UK market. We offer expert guidance to ensure smooth and compliant market entry.
THE COSMETICS INDUSTRY
By combining regulatory expertise with strategic guidance, our consultants ensure the successful development, marketing, and distribution of cosmetic products. We help make sure your products are safe, effective, and fully compliant with legal requirements, paving the way for your success in the market
FOOD SUPPLEMENTS
From product classification and ingredient compliance to labeling, safety assessments, and post-market surveillance, we offer comprehensive support to ensure your products are both compliant and safe for the market.