Regulatory Affairs

Finding solutions and oriented vision based on your strategic business development

QualitecFarma® is an external Regulatory Affairs department that provides regulatory support to Pharmaceutical companies and related firms willing to shore up their processes and make the best use of their regulatory strategies.

QualitecFarma® is a granted Marketing Authorization Holder, with the purpose of being a strategic partner of companies in registration procedures, being their “subsidiary” or “affiliate” and optimizing their intangible assets.

We carry out projects ranging from leaflet translation to full development of dossiers for registration, variations, periodic safety update reports and renewals (pharmacovigilance), updating and adapting documents, expert reports and other activities related to the R&D area of the company.

QualitecFarma® has a broad experience in the development, evaluation and management of dossiers and has been the first Spanish company in introducing the NTA 2001 (CTD) requirements in direct collaboration with the responsible persons from the management of procedures department of the Health Authorities, with whom we have closely collaborated in other projects within the regulatory field.
Main Regulatory Affairs activities

Global development of
registration procedures

Local and international registration procedures management, MRPs and DCPs

01.

eCTD compilation, dossier evaluation and submission. Management till Marketing Authorization is granted

02.

Pharmacovigilance
management

03.

Pricing and
reimbursement

04.

Due diligence

Technical support and evaluation of profitable dossier acquisition by technical evaluation of the dossiers. ASMF development and assessment report

05.

R&D of new expert reports. Wide experts network

06.

General Regulatory & Scientific Support.
Scientific Advice.
Project Management

07.

LoD emission
(pre-assessment reports).
Gap analysis on variations and strategy definition

08.

Increase of customer company profits by parallel dossier submission

09.

Establishment of new pharmaceutical companies. Quality summary and dossier

10.

Updates on regulatory requirements

11.