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
AxeRegel can also provide:
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:
- Quality Assurance services: Drafting of Standard Operational Procedures (SOP)
- Nutrivigilance services
Recent posts
14/04/2022 : How to manage the impact of the war in Ukraine on clinical trials?
15/03/2022: The iodine tablet rush
28/02/2022: Today is the rarest day of the year
17/02/2022: COVID-19: is green alert level imminent?
10/02/2022: Everybody can get a booster shot of COVID-19 vaccine
31/01/2022: New EU regulation on clinical trials of medicinal products: what is changing?
27/01/2021: Teleworking: how to stay in touch?
20/01/2022: Covid-19 vaccines: Where do we stand one year later?
06/01/2022: COVID-19: How to reconcile business continuity and worker protection?
Recent posts
How to manage the impact of the war in Ukraine on clinical trials?
Posted 2022-04-14
The war in Ukraine is causing disruptions in the conduct and planning of clinical trials. Although these disruptions are most severe in Ukraine, other countries are also affected, for example due to the arrival of refugees f (...)
GMP, GCP and IRIS guides
Posted 2022-04-07
The guide for applicants and Marketing Authorization Holders (MAH) involved in GMP and GCP inspections coordinated by the EMA as well as the IRIS guide have been updated. Good Manufacturing Practices (GMP) are the principles (...)
