Whether there is a need for a company to develop new products or they are already manufacturing such products, Omeramak Consulting Services ensures that the organization is compliant with applicable regulatory standards and requirements. Our experienced consultants will work with the organization either remotely or onsite to help their teams to anticipate and mitigate potential issues before they occur. Further, our experts will help to resolve such issues in planning and execution for an effective outcome including any corrective and preventive actions that focus in the following areas:

• Process development and optimization
• Design control
• Quality Management System
• GMP, GCP, GLP, ISO standards
• Validation
• CAPA
• EU Medical Device Regulation (EU MDR) compliance
• Pharmacovigilance risk audits and regulatory inspection readiness