Regulatory Affairs

• Drug registration: investigation and selection of pre-clinical and clinical information
• Development of extended and reduced information for prescription
• Strategic review of the final registration dossier to be submitted to regulatory agencies
• Regulatory aspects of drug supplies management - including labeling and importation requirements
• Monitoring, follow-up and control of registration procedures until authorization
• Medical regulatory affairs

MMATISS has over 12 years of experience with observational and outcomes programs in many therapeutic areas. We offer a full range of registry services to pharmaceutical and medical society clients. Registries can assess clinic, economic, quality of life, document patterns of care, and confirm safety profiles for patients who are treated with a specific product, procedure or have a specific condition.

MMATISS provides an operational team of highly qualified individuals dedicated to your registry programs. They will work with your team to select the appropriate services to assure the rapid, efficient, cost-effective management of every program.