WiseHS provides a range of licensing consultancy services to entities that manufacture, distribute and trade human medicines, medical devices, active substances and cosmetic & body care products.

Manufacturer

- Regulatory Support
- Preparation and/or revision of documents required by the Competent Authority
- Support in the registration process for Competent Authorities
- Elaboration and/or revision of the Site Master File
- Verification of compliance with Good Manufacturing Practices | GMP
- Preparation and/or revision of Standard Operating Procedures | SOPs
- Management of change requests

Distributors

- Regulatory Support

- Preparation and/or revision of documents required by the Competent Authorities

- Support in the registration process for Competent Authorities

- Management of change requests

- Preparation and / or revision of the Good Distribution Practice Procedures Manual

Manufacturer

- Regulatory Support
- Preparation and / or revision of documents required by the Competent Authorities
- Support in the notification process to Competent Authorities
- Management of change requests

Distributors

- Regulatory Support
- Preparation and/or revision of documents required by the Competent Authorities
- Preparation and/or revision of the Good Distribution Practice Procedures Manual
- Management of change requests
- Support in the notification process to Competent Authorities

Manufacturer

- Regulatory Support
- Preparation and/or revision of documents required by the Competent Authorities
- Support in the notification process to Competent Authorities

Distributors

- Regulatory Support
- Preparation and/or revision of documents required by the Competent Authorities
- Support in the notification process to Competent Authorities

Manufacturer

- Regulatory Support
- Preparation and/or revision of documents required by the Competent Authorities
- Support in the notification process to Competent Authorities

Distributors

- Regulatory Support
- Preparation and/or revision of documents required by the Competent Authorities
- Support in the notification process to Competent Authorities