Quality
Working with Alfred Gera & Sons Ltd., companies can be assured that the highest quality standards will be adhered to. We offer quality, confidence and trust.
All activities are carried out in line with the latest EU-GDP, Malta Medicines Authority and EC guideline requirements with a logistics infrastructure that is fully audited, compliant and temperature mapped. Our Quality Management System also encompasses customer focus, emergency and contingency plans as well as best health and safety practices.
Our documented Quality Management system has been prepared to meet the requirements of the International Quality Management Standard ISO 9001:2008, Article 10 of the European Council Directive 2001/83 EEC, 2011/62 EEC and European Commission Guidelines 2013/C 343/01.
The application of the system is the importation, receipt, storage and wholesale distribution of pharmaceutical products, toiletries, food products and allied lines.
Regulatory
At Alfred Gera and Sons Ltd. we understand that a pharmaceutical company’s focus is on developing the product portfolio and getting products to market. Understanding the issues involved in managing pharmaceutical regulations can be a challenge. Our regulatory department, comprising highly trained and experienced professionals dedicated to regulatory operations, is the right partner you need in Malta. We have a long track record working with international pharmaceutical corporations as well as all the competent Maltese Authorities.
Our regulatory services are offered to all suppliers using our logistics services, as well as on a standalone basis to others. Through our network of partnerships, we are in an ideal position to help with every stage of a product’s life, from supporting license applications to managing day to day regulatory issues to whatever level you need:
- Pharmaceutical and Non Pharmaceutical Regulatory services
- Medical Information (MI) and Pharmacovigilance (PV)
- Licensing Authority applications
- Qualified Person (QP) batch release
- Liaison with competent authorities on all aspects of compliance
- Analytical testing
- Contract Secondary Repackaging
- Responsible Person (RP) Services
- Site visits and auditing
- Preparation of sites for inspections
- Review & implementation of quality systems
- GDP/GCP/GMP Expertise
- Full Quality System Implementation