A Willis Consulting

STRATEGIC PLANNING FOR SUBMISSIONS

• Comprehensive analysis of the product and its market environment
• Market access
• Analysis of all applicable regulatory requirements
• Intellectual propery and intelligence gathering
• Advanced lifecycle management

ELABORATION OF MA DOSSIER SPECIFIC DOCUMENTS

Preparation of all Documentation required for Dossier Submission including:

Module 1 - Texts, ERA, RUT, PV Summary, RMP;

Modules 2, 3, 4 and 5 - Expert Reports, CMC

Our sister company PHAGECON can also act as MAH and PV Provider for specific procedures.

We can assemble in accordance with each client/NCA requirements:

a.CTD Paper Dossier;

b.NeeS Format;

c.e-CTD Format.

MA MAINTENANCE ACTIVITIES

While predicting long term variations according to the regulatory intelligence and assuring the dossier consolidation we can assist in:

• Renewals
• Line extensions
• MAH transfers

SUBMISSION OF MA DOSSIER UNTIL APPROVAL

A 360º service including

• Dossier submission through different formats in the EU and other emerging countries
• Liaison with the authorities for slot booking and management of the evaluation phase
• Answering to LoDs that may arise from the authorities
• National phase management, including all applicable translations and mock up preparations
• We ensure a comprehensive and critical analysis of each procedure, assuring its success and reduction of LoDs that may arise