AF Pharma Service Regulatory Services
Medical Devices, Cosmetics, Amazon Products and General Consumer Products

​​​EU Authorized Representative | UK Responsible Person | FDA U.S. Agent | Australian Sponsor

AF Pharma Service provides regulatory compliance, product registration and market access support for companies selling medical devices, cosmetics, Amazon products and general consumer products in the European Union, United Kingdom, United States and Australia.

We support manufacturers, brands, distributors and online sellers that need a reliable regulatory partner to understand product requirements, prepare compliance documentation, review labels and claims, complete registrations and act as regulatory representative where required.

Our services are designed for companies that need clear, practical and cost-effective support before placing products on the market or responding to requests from authorities, Notified Bodies, Amazon or other online platforms.

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Regulatory Representation and Market Access

AF Pharma Service acts as regulatory representative and compliance partner for international companies entering regulated markets.

Our key services include:

• Medical Device Regulatory Support: EU Authorized Representative, UK Responsible Person, FDA U.S. Agent, Australian Sponsor, MDR, IVDR, CE marking, UKCA marking, MHRA registration, FDA establishment registration, device listing, 510(k) support and technical documentation review.

• Cosmetic Compliance Services: EU and UK Responsible Person, CPNP notification, SCPN notification, Product Information File, CPSR coordination, cosmetic label review, INCI review, claims assessment and MoCRA support.

• Amazon Compliance Support: Amazon Responsible Person, product compliance files, label and claims review, restricted product support, documentation packs and assistance with Amazon compliance requests.

• General Product Compliance: GPSR Responsible Person support, consumer product safety documentation, labelling review, warnings, instructions for use, Declaration of Conformity review and EU / UK market access assessment.

Why Work With AF Pharma Service?

With more than 14 years of regulatory experience, AF Pharma Service helps companies identify the correct regulatory pathway for their product and target market.

We work across medical devices, cosmetics, food supplements, Amazon compliance and general consumer products, allowing us to support companies with mixed product portfolios and cross-border market access needs.

Our approach is practical and business-focused. We help you understand what documents are required, what claims can be used, what registrations are needed and what evidence may be requested by authorities or online platforms.

We support clients with:

• regulatory classification and market access strategy;

• EU, UK, USA and Australia compliance requirements;

• product registration and notification;

• technical documentation and compliance file review;

• label, IFU, packaging and claims assessment;

• quality system and ISO 13485 support;

• Amazon Responsible Person and product compliance requests;

• communication with regulatory authorities and online platforms when needed.

Practical Regulatory Support for International Markets

Whether you are launching a medical device, notifying a cosmetic product, preparing an Amazon compliance file, registering with the MHRA, appointing an EU Authorized Representative, looking for a UK Responsible Person, preparing an FDA 510(k), or reviewing a general consumer product under the EU GPSR, AF Pharma Service can help you understand the requirements and prepare the correct documentation.

We provide clear regulatory guidance, transparent fees and personalised support for startups, small and medium-sized companies and international manufacturers.

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