Our full range regulatory affairs solutions and services are dedicated to delivering the highest quality support, assistance and regulatory approvals. We follow the needs of our customer and their portfolios, as we work with a wide range of product categories: medicinal products, medical devices, cosmetics, and food supplements. Our Regulatory Affairs team has comprehensive expertise and assures quality and accuracy for each task. All team members have majored in life sciences. Our consulting caters to a small scale pharmaceutical looking to expand its horizon, or you need guidance for OTC authorization.

From preparing and maintaining dossiers to providing translation services, our experts make sure our clients can achieve their goals.

Our competency is in the pharmaceutical, biotechnology, and medical devices industry with expertise in both traditional and agile processes. The flexible validation services offered are user-oriented, efficient, and scalable to meet the requirements of any size company.Risk management with a risk-based validation approach. Services we offer include but are not limited to: Analysis of the Quality Management System (QMS) with regard to the validation processes, Creation of a validation plan as a definition of the project and validation strategy, Performance of Computer System Validation (CSV), including equipment and system qualification ,GAMP®5 based solutions and use of the V-model or alternative procedures (further customer-specific compliance solutions are possible) , Creation of Standard Operating Procedures (SOPs) and training management , Consulting on data integrity , Complete audit management and support and Support for validation of the cloud solutions Infrastructure as a Service (laaS), Platform as a Service (PaaS), and Software as a Service (SaaS)

Our wide variety of expertise means we will support your organization with world-class Medical Affairs solutions, when you require them in the following streams:
• Publication Strategy, planning and execution
• Promotional Review Committee
• Advisory Board planning and execution
• Product Website
• Product Presentations
• Disease Awareness Presentations
• Key Opinion Leader management

Our experience and expertise means you can personalize your clinical trial operations. From CRAs that are dedicated to your project, a responsive, hands-on senior management team, and a process that’s agile and able to accommodate the unique needs of each personalized medicine trial, we deliver what your project needs to succeed.
Services we offer include:
• Clinical Data Management
• Biostatistics and Programming
• Medical Writing

Pharmacovigilance services offered by consist of but are not limited to pharmacovigilance consulting – e.g. benefit-risk analysis, European Economic Area (EEA) Qualified Persons for Pharmacovigilance (QPPV), local QPPV, Safety data exchange agreement (SDEA), Development of risk management plans (RMPs), Development of pharmacovigilance system master file (PSMF), Auditing services, Development of standard operating procedures (SOPs), post-marketing and Clinical trial case processing, validated safety databases, aggregate report writing, literature search, and regulatory reporting.