"first in human" dossier preparation
Advice & Assistance for compliance with the local requirements
Advice On Registration Strategy And Health Authority Requirements
Assistance In Compassionate Use Programs
Clinical Trial Applications
Coordination Of The Price & Reimbursement Applications In Eu Countries
Evaluation Of The Adherence To Regulations And Applicable Guidelines For Regulatory Dossiers
Facilitation Of Local Concerns Via A Network Of Partners In Eu Countries And In Usa
GMP facilities desing and validation
GXP staff training
Liaison With The Regulatory Authorities
Local Pharmacovigilance Support
Management Of Regulatory Procedures (Maa, Variations, Ma Renewal & Transfer)
Orphan Drug Designation Applications
Paediatric Investigation Plan (Pip) Applications
Preparation Of National Price & Reimbursement Applications
Preparation Of Registration Dossiers For Marketing Authorisation And Variation Applications In Ctd A
Project Management
Readability Testing Of Pil
Regulatory Due-Diligences
Regulatory Revision Of Development Plans
Revision Of Promotional Material
Revision Of Spc, Pil And Labelling
Scientific Advice Requests
Support During The Negotiation Process With The Authorities
