AxeRegel

Regulatory and pharmaceutical consulting services for the life sciences industry through the lifecycle of their products

Regulatory and Quality Assurance consulting services

For more information about AxeRegel services, please download our brochure or contact us.

Cosmetic products consulting services

AxeRegel offers cosmetic products companies the following cosmetic consulting services:

  • Advise and review of product labels, inserts, or advertising for EU compliance
  • Review of ingredients for EU compliance
  • Advising on product claims, ingredient listings and warning declarations
  • Preparation of safety material data sheets (MSDS)
  • Guidance for companies responding to warning letters
  • Assistance to regulatory compliance
  • Submission of EU cosmetic notifications through the Cosmetic Product Notification Portal (CPNP)
  • Preparation and review of Product Information Files (PIF’s)
  • Request for Certificates of Free Sale (CFS), for companies exporting outside the EU
  •  Responsible person services

AxeRegel can also provide:

  • Quality Assurance services: evaluation of manufacturing quality systems, audits and drafting of Standard Operational Procedures (SOP).
  • Cosmetovigilance services


Medicinal products consulting services

Registration

  • Regulatory strategy
  • Dossier preparation
  • Preparation of responses to deficiency letters and queries from the regulatory authorities

Regulatory maintenance

  • Post-approval lifecycle maintenance (classification and preparation of variations…)
  • Implementation of changes in the product information (SmPC, package leaflet, labeling…)
  • Renewal applications
  • Marketing Authorisation Holder transfers
  • Regulatory intelligence


Medical Devices consulting services

  • Advise and review of product labels, inserts, or advertising for EU compliance
  • Determine the classification of a medical device
  • Preparation of technical dossiers (CE marking, export...)
  • Facilitate interaction with regulatory agencies
  • Request for Certificates of Free Sale (CFS), for companies exporting outside the EU
  • Notification of Medical devices to the Authorities
  • Provision of regulatory compliance advice

AxeRegel can also provide:

  • Quality Assurance services: Drafting of Standard Operational Procedures (SOP); Management of product complaints.
  • Materiovigilance services



Food supplements consulting services

  • Advise and review of product labels, inserts, or advertising for EU compliance
  • Verification of nutrition and health claims
  • Preparation of technical and administrative dossiers
  • Request for Certificates of Free Sale (CFS), for companies exporting outside the EU
  • Notification/submission to the Authorities

AxeRegel can also provide:

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