The Regulatory Affairs departments in the pharmaceutical industry are facing increasing regulatory requirements for both paper dossiers, electronic dossiers and eCTDs as the form of the submission and the formatting and layout of the documentation is getting more and more critical.

Our highly qualified and experienced staff can help you in every step of your compilation processes ensuring that your submissions will be in compliance with the requirements from the relevant authorities.

 

Pharmaceutical eConsulting Copenhagen A/S has extensive experience with compiling multiple submission types across regions, including MAA, CTA, NDA, ANDA, IND, NDS matching the requirements from all health authorities. Submissions can be delivered in any format electronically with XML (eCTD), electronically (volumised PDF), paper or hybrids according to client and relevant health authority requirements.