Being the main reason for the Company's inception, the growing and increasingly tight Regulatory Affairs requirements in Europe and other continents, has led to continuous development of consulting services in this area.
PHAGECON, on the evolutionary edge of these companies, provides its clients a service that guarantees not only full compliance with all applicable legal requirements and required deadlines, in a cost-effective way but also integrates a critical review and prospective analysis of the needs of each client.
Considering each project as an individual element, with specific needs and requirements, PHAGECON gives strategic input on each process that ensures quicker approvals and dramatically reduces the possibility of occurrence of LoDs during its client's procedures. This holistic approach is applied throughout the life cycle of the drug, since the MA Submission until its withdrawal.
PHAGECON - Your regulatory partner throughout the entire Life-Cycle
Strategic Planning for Marketing Authorization Submission
- Comprehensive Analysis of the Product and its Market Environment;
- Market Access for Commercial Advice;
- Analysis of all applicable Regulatory Requirements in any of the desired territories;
- Intellectual Property and Intelligence Gathering
Will allow to develop a Global Midterm strategy to ensure product growth and Market Maintenance.
Gap-Analysis of all Documentation
- Comprehensive analysis of the documentation considering the different requirements from different regions around the planet;
- Preparation of an Extended Report underlining major and minor findings and suggesting all applicable adaptations what will be necessary for Dossier Compliance.
Elaboration of Marketing Authorization 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 - Clinical Overview, Non-Clinical Overview, CMC Development and Consultancy for the best study design to support safety and efficacy.
- PHAGECON can also act as MAH and PV Provider for specific procedures.
Dossier Preparation for Submission
- After elaboration of all the documentation, PHAGECON can assemble in accordance with each client/National Competent Authority requirements:
- CTD Paper Dossier;
- NeeS Format;
- e-CTD Format.
PHAGECON is widely recognized for its excellent eCTD publish services working tightly with its service provider (EXTEDO).
Submission of Marketing Authorization 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.
PHAGECON ensures a comprehensive and critical analysis of each procedure, assuring its success and reduction of LoDs that may arise.
- Price and Reimbursement Requests;
- Mock-up Review before Market Entrance;
- Obtain License for Distribution of the Product;
- Partner Search for Product Distribution;
- Promotional Material Review and Elaboration;
- 3rd Market entrance after approval of MA in an EU Country (Africa, Asia and South America).
Marketing Authorization Maintenance Activities
While predicting long-term variations according to the regulatory intelligence and Assuring the Dossier Consolidation PHAGECON performs:
- Line Extensions;
- MAH transfers;
- Avoid Application of Sunset Clauses;
- MA Withdrawn and Submission of Copies and Duplicates for 3rd parties.