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 registration dossier
» Compilation of registration dossiers in any format, especially as common technical document (CTD)
» Follow-up of submitted documentation
» Dealing with deficiency lists and variations
» Preparation of drug master files
» Applications of certificates of suitability
» Allergenicity and photosensitization tests on topical dosage forms.
» Expert opinions and reviews, especially for regulatory compliance