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Services for the pharmaceutical industry

[/vc_column_text][vc_empty_space height=”50px”][/vc_column][/vc_row][vc_row][vc_column width=”1/3″][vc_column_text]Registration of a Medicinal Product

• Preparation, submission and co-ordination of MRP applications as RMS and CMS
• Preparation and submission of abridged Marketing Authorisation applications
• Preparation of application forms, SmPC, Patient Information Leaflets and packaging ensuring that technical, regulatory and commercial requirements are met
• Monitoring the progress of MA applications, minimising delays and anticipating potential issues.

[/vc_column_text][/vc_column][vc_column width=”1/3″][vc_column_text]Life-Cycle Maintenance

• Preparation, submission and co-ordination of national and MRP variation applications.
• Licence Transfer applications in the EU
• Preparation, submission and co-ordination of product licence renewals and other amendments to product licences

[/vc_column_text][vc_empty_space height=”20px”][vc_column_text]Other Services

• eCTD Publishing: Fast, efficient turnover
• Dossier conversions from US to EU format
• Regulatory due diligence on company for acquisition

[/vc_column_text][/vc_column][vc_column width=”1/3″][vc_column_text]Clinical Trial Support

• Arrange clinical trial to support MA applications
• Monitor and report on progress of clinical trial
• Highlight potential issues and minimise delays
• Co-ordinate trial with related regulatory activities

[/vc_column_text][vc_empty_space height=”20px”][vc_column_text]Management, Supervision and Training

• Design and lead projects
• Supervise and train staff

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