Puerto Galiano has a Registrations Department, specialising in all manner of regulatory procedures affecting the pharmaceutical and para-pharmaceutical industry. Our team is made up of chemical and pharmaceutical technicians with over 10 years’ experience in the field, absolute experts in all the procedures and regulations involved in a highly sensitive and specialised task.
At PUERTO GALIANO we manage and resolve all manner of drug registration issues, follow-up of case records with the Spanish AEMPS drug administration, applications for new installations, compliance with GMP regulations, pharmacovigilance, etc.
All performed by skilled technical staff with huge experience in the industry, covering the entire sector of medicinal products for human use.
- Drug Registration.
- Validation of registration dossiers.
- Expert reports.
- Five-yearly re-validations (renewals)
- Modifications to the conditions of the Medication Authorisation.
- Follow-up of case records with the AEMPS
- Price justification applications.
- Regulatory outsourcing services.
- Execution of Readability Tests.
- Application for the Braille Certificate.
- Pharmacovigilance services.
Cosmetics Industry and Personal Hygiene
Our extensive experience of cosmetics allows us to administer and resolve all manner of registration issues with cosmetics, follow-up case records with the AEMPS, successful issuance of cosmetics manufacturing authorisations, etc.
- Notification of Cosmetics and Personal Hygiene Products.
- Registration dossiers.
- Application for National Code.
- Technical Dossier.
- Installations Application and Cosmetics Company Authorisations. Renewal of the Authorisation.
- Consultancy, development, cosmetics.
Healthcare Products Industry
With each passing day it becomes more challenging for a healthcare product company to keep properly up-to-date. Our experience and knowledge of the sector make this task simpler, offering the sector services such as the preparation of CE Marking dossiers, extension of Quality Systems, ISO 13485 standards, etc.
- Manufacturers’ and Importers’ Operational Licence Application
- Confirmation of Quality System Compliance.
- Notification of Parties Responsible for Market Release.
- Authorisation in the Healthcare Products Register.
- CE Marking Application
- Preparation of Technical Product Dossiers
- Application for the National Code
- Communication of Distribution and Sale
At Puerto Galiano we work for the food industry by delivering solutions for the presentation of new notifications of food supplements and/or issuance of authorisation at the Belgian Food Safety Agency (NUT Code).
- Application for General Sanitary Registry of Food (RSI).
- Review of Labelling for legal compliance.
- Communication of Market Release.
- Notification of Food Supplements
- Application for National Code