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Areas of Expertise:
» Human Medicines
» Veterinary Medicines
»
Cosmetics
» Medical Devices
» Borderline products
» Homeophatic products
» Herbal medicinal products
» Radiopharmaceutical
products
» Biotechnology products
» Nutritional products
MA Procedures:
» National Procedures
» Mutual
Recognition Procedures
» Decentralized Procedures
» Centralized Procedures
Dossier Preparation:
» Complete,
Abridged and Bibliographic Applications
» Chemistry & Pharmacy/Quality, Toxicology/Preclinical studies, Clinical (parts
II, III & IV and corresponding CTD modules)
» Regulatory Strategies for New Products Development
» Regulatory Submission
Strategies
» Assessment of Regulatory Data
» Regulatory Intelligence
» Project Management
» Pricing applications
»
Reimbursement applications
» Technical Translations
» Regulatory Affairs Trainings
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eCTD - Preparation of registration dossiers
Readability
Testing of Patient Leaflets
MA Maintenance Activities:
» Type IA, IB & II variations
» Preparation & Labeling
analysis (SPC, PIL)
» Adapting from old NtA format to the new CTD format
» Expert Reports
» Pharmacovigilance
»
MA Renewals & PSUR
» Urgent safety restrictions
» Preparation of Regulatory and Pharmacovigilance procedures (SOP)
»
Revision of medical publications (adverse events)
Clinical Trials:
» CTA applications for submission to Competent
Authority
» CTA applications for submission to Ethics Commitee
» Support to Technical Directorate activities
»
Preparation of Quality Assurance SOPs
» Distribution Authorisation Applications
» "AUE" Applications (Special Authorisations
to use a medicinal product at hospital level that is not available in Portugal)
For further information on our Services
click here.
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