Finding solutions and oriented vision based on your strategic business development
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.
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
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.
Global development of
Local and international registration procedures management, MRPs and DCPs
eCTD compilation, dossier evaluation and submission. Management till Marketing Authorization is granted
Technical support and evaluation of profitable dossier acquisition by technical evaluation of the dossiers. ASMF development and assessment report
R&D of new expert reports. Wide experts network
General Regulatory & Scientific Support.
Gap analysis on variations and strategy definition
Increase of customer company profits by parallel dossier submission
Establishment of new pharmaceutical companies. Quality summary and dossier
Updates on regulatory requirements