We provide compliance solutions and consultancy services for medicinal products for human and for veterinary use, medical devices and other healthcare products.
Regulatory Affairs
- Life-cycle management for medicinal products and medical devices
- Review of product information: translations in local languages (Dutch, French, German), review of translations
- Assistance and review of technical files
- Regulatory intelligence in the Benelux
Quality Assurance
- Review of procedures and processes for compliance with good distribution practices (GDP) guidelines and good manufacturing practices (GMP) guidelines
- Assistance with the preparation, management and follow-up of national health authority inspections
- Temperature mapping of warehouses and transportation vehicles
- Compliance review and gap analysis with medical device regulations
- Audits of suppliers and service providers, internal audits, preparation, management and follow-up of customer audits
- Review of quality and technical agreements
- Responsible person (GDP), qualified person (GMP), 24/7 availability
Information and Publicity
- Review and approval of information and publicity
- Certification of translations
Pharmacovigilance
- Local contact person for pharmacovigilance in the Benelux
- 24/7 availability
- Local literature screening: we have subscriptions to 50+ local journals in the Benelux and France that are not indexed in international databases
Other Healthcare Products
- National registration of food supplements
- National registration of biocides