MERICON

For governmental health and environmental authorities we give assistance with evaluation and reviewing of documentation.

We lecture at universities and give courses and seminars within our disciplines.

Regulatory affairs management for the pharmaceutical industry

MERICON has many years’ experience in assisting pharmaceutical industry in regulatory affairs management. We can offer assistance at all levels of regulatory affairs management.

Regulatory affairs services

Our regulatory affairs services include:

• Assisting in contact with the Norwegian Medicines Agency (NoMA)
• Providing guidance according to national procedures and requirements
• Preparing documentation for common technical document (CTD)
• Translating summary of product characteristics (SPC), patient information leaflet (PIL), labelling and other relevant documents related to marketing authorisation
• Readability testing of package leaflet
• Assistance regarding submission of variation to NoMA
• Preparing and updating product information in the Norwegian Pharmaceutical Product Compendium (Felleskatalogen™)
• Ensuring health and public marketing information is provided according to Norwegian law

Quality assurance of pharmaceutical ingredients

MERICON has experience within quality assurance in connection with manufacturing of pharmaceutical ingredients according to GMP.

Personalised services for clinical studies

The clinical product development process has become a complex orchestration of individual researchers, commercial sponsors, technology providers, regulatory agencies and patient consumers. Successful outcomes are largely dependent on how people and organisations work together.

We offer a personalised service from a small team, adaptable to client requirements and with a focus on quality and scientific standards meeting the international and national requirements.

Clinical research services

Our clinical research services include:

• Product development planning
• Protocol design
• Preparation for regulatory authority and ethics committee notifications
• Case report form (CRF) design
• Monitoring
• Report writing

Statistics and data management for clinical trials

We have a solid foundation of knowledge in medical science and statistics, as well as extensive practical experience in clinical studies. Our statistical services include:

• Sample size estimation
• Statistical analysis plan
• Randomisation
• Data management
• Statistical analysis
• Statistical report
• Pharmacokinetic calculations