Regulatory Affairs, Consulting and Program Management

The drug regulatory affairs fairs group offers regulatory services for human and veterinarian medicinal products such as new active ingredients, generics, herbal medicinal products and biotech products.

• Advice on regulatory requirements and application strategies 
• Negotiations with the authorities 
• Preparation of all parts of a registrationdossier 
• Compilation of registration dossiers in anyformat, especially as common technicaldocument (CTD)
• Follow-up of submitted documentation 
• Dealing with deficiency lists and variations 
• Preparation of drug master files 
• Applications of certificates of suitability 
• Expert opinions and reviews, especially for regulatory compliance