A Willis Consulting

Driving Success Through Excellence in Services

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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

Regulatory Services

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.

GAP ANALYSIS OF ALL DOCUMENTATION

Comprehensive analysis of the documentation considering the differenct reguirements from different regions

Preparation of an extended report underlining major and minor findings and suggesting all applicable adaptations that will be necessary for Dossier Compliance

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

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