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"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

 
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