Key services:
Customer representation towards national regulatory bodies.
Developing regulatory submission strategies.
Preparation of documents in compliance with the requirements of local regulations for registration including creation of some parts of the dossier, application form and translations for the new product registration / renewal procedure until issuance of Marketing Authorization.
Submission of the application to competent authority, correspondence and follow-up with the authorities during procedure.
All post-approval regulatory activities: transfer of Marketing Authorization, approval of packaging according to local regulations, submission of variations and line extensions, renewals, PSUR's submission, submission of promotional materials, and all other related regulatory activities to ensure compliance with national legislation.
Reports of analysis and impact of regulatory change.
Regulatory Intelligence activities.
Pharmacovigilance and safety.
Professional and scientific literature searches.
