Regulatory Services
- Preparation of new marketing authorization applications for medicinal products and submission to Health Authorities
- Preparation of variations of medicinal products and submissions to Health Authorities
- Preparation of renewals of medicinal products and submissions to Health Authorities
- Translation of SmPCs, PIL, Labelling
- Preparation and submission of new medical device information to Health Authorities
- Preparation and submission of product information for cosmetics and health supplements to Health Authorities
- Advice and guidance on registration procedures
- Review and evaluation of product data before submission to Health Authorities
- Dossier preparation and Scientific writing
- Pre- and Post- marketing regulatory support