Over the years LCA has established an in-depth expertise in establishing contacts with health authorities.
The Regulatory Affairs department has been helping local Belgian, European and non-European pharmaceutical companies in the different administrative, pharmaceutical and clinical steps for the compilation and follow-up of drug dossiers, according to both the local (Belgian) and European Procedures

• Writing and compilation of full CTD registration files for new medicinal products.
• Writing and compilation of full CTD registration files for abridged bibliographical or generic applications.
• Writing and compilation of Clinical Trials applications, including IMPD section
• Writing and compilation of CMC sections of CTD registration files.
• Writing and compilation of Type IA, Type Iain, Type II, and Line extensions registration files.
• Writing and compilation of renewal applications.
• Translation of scientific texts (pharmaceutical, medical and para-pharmaceutical fields)

Specific for the Belgian territory LCA as the competencies in-house to provide services under the responsibility as:

• Qualified Person pursuant to 2001/83/EC art 51 or art 103
• Qualified Person for advertising and information pursuant to Royal Decree April 7th, 1995, art 13