Regulatory Affairs Pharma Flyer
Harlan Laboratories offers regulatory services
for human and veterinary 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
- Expert opinions and reviews, especially for regulatory
compliance