Medical Device, Cosmetic, Amazon & General Product Compliance
Regulatory Representation, Registration & QA Support

AF Pharma provides regulatory representation and market access support for manufacturers, brands and online sellers placing products in the EU, UK, USA and Australia.

​We act as your regulatory contact for:

• Medical Devices → EU Authorized Representative, UK Responsible Person, FDA U.S. Agent, Australian Sponsor, MDR, IVDR, CE marking, UKCA, MHRA registration, FDA registration, device listing and 510(k) support.

• Cosmetics → EU / UK Responsible Person, CPNP notification, SCPN notification, PIF, CPSR, cosmetic label review, claims compliance and MoCRA support.

• Amazon Compliance → Amazon Responsible Person, product compliance documentation, listing support, restricted product review and response to Amazon compliance requests.

• General Products → GPSR Responsible Person, product safety documentation, labelling review, consumer product compliance and EU / UK market access support.

AF Pharma helps companies prepare and maintain compliant quality systems for regulated products.

Our support includes:

• Medical Devices → ISO 13485 implementation, QMS review, FDA QSR / QMSR readiness, technical file support, PMS, PMCF, complaint handling and CAPA procedures.

• Cosmetics → cosmetic quality documentation, GMP support, PIF structure, CPSR coordination, supplier documentation review and product compliance files.

• Amazon Products → compliance file preparation, product documentation review, safety certificates, test reports and corrective actions for blocked or restricted listings.

• General Products → product safety files, GPSR compliance documentation, risk assessment, traceability, labelling checks and supplier evidence review.

AF Pharma prepares and reviews the documentation required to place products on regulated markets.

Our services include:

• Medical Devices → MDR and IVDR technical documentation, CE marking files, UKCA documentation, MHRA registration, FDA 510(k), De Novo support, FDA establishment registration, device listing, CER, PMS and regulatory gap assessments.

• Cosmetics → Product Information Files, CPSR coordination, CPNP / SCPN notification, cosmetic claims review, INCI review, MoCRA support and label compliance.

• Amazon Compliance → documentation packs for Amazon requests, responsible person evidence, test reports, product certificates, label review and compliance explanations.

• General Products → GPSR technical documentation, Declaration of Conformity review, product safety assessment, warnings, instructions for use and market access checks.

AF Pharma supports sellers, manufacturers and brands with Amazon compliance requirements in the EU, UK, USA and Australia.

Our services include:

• Medical Devices → Amazon medical device compliance review, CE marking, UKCA, MHRA registration, FDA registration, 510(k) documentation and device classification support.

• Cosmetics → cosmetic responsible person evidence, CPNP / SCPN support, PIF / CPSR documentation, label review and cosmetic claims compliance.

• Amazon Responsible Person → EU Responsible Person, UK Responsible Person, product compliance documentation and support with Amazon compliance requests.

• General Products → GPSR documentation, product safety files, test report review, labelling checks and restricted product support.

AF Pharma provides practical training for startups, manufacturers, distributors and regulatory teams working with regulated products.

Training can be delivered online or onsite and may cover:

• Medical Devices → MDR, IVDR, CE marking, UKCA, FDA registration, 510(k), ISO 13485, PMS, PMCF, clinical evaluation and technical documentation.

• Cosmetics → EU / UK cosmetic compliance, Responsible Person obligations, PIF, CPSR, CPNP, SCPN, claims and labelling.

• Amazon Compliance → Amazon documentation requests, Responsible Person requirements, listing compliance, restricted products and how to respond to Amazon compliance teams.

• General Products → GPSR, product safety documentation, labelling requirements, warnings, instructions for use and consumer product compliance.