What We Do
Welcome to Evoltrace, We support marketing authorization holders, manufacturers, and exporters worldwide. Our team has extensive experience in implementing compliances in the pharmaceutical industry across the EU, US, MENA and CIS regions. We ensure your regulatory journey is seamless and successful. Join us at Evoltrace and experience excellence in pharmaceutical compliance support.
Compliance Implementation
To start serialization, first register with the appropriate regulatory bodies. Regulations for pharmaceutical serialization differ by country.
After registration with regulatory authorities, the next step is selecting a vendor for your serialization system. This vendor will provide the necessary technology and support to ensure compliance with serialization regulations.
After choosing a vendor, the next step is implementing the serialization system within your company. This involves connecting the system to the European Medicines Verification System (EMVS) and the Organized Market System (OMS) to ensure all information is accurate and up-to-date.
Once the serialization system is implemented, update your company’s SOPs (Standard Operating Procedures) and train your employees on how to use it. This ensures everyone understands serialization processes and can comply with regulations.
Once the serialization system is implemented, update your company’s SOPs (Standard Operating Procedures) and train your employees on how to use it. This ensures everyone understands serialization processes and can comply with regulations.
Once the serialization system is set up and your employees are trained, you can commence the production process and begin reporting to the government as mandated. This is a continuous process that demands ongoing support.
- Subject Matter Experts
- Technical Consultants
- Validation Specialists
- Implementation Project Manager
- Business Analysts
- Program Manager
- Data Analysts
- Risk Advisory and Consulting Services
- Regulatory Compliance Assessment
- Customized Serialization Strategy
- Technology Integration
- Validation and Testing
- Training and Change Management
- Ongoing Support and Hypercare
- Data Analytics
- Reporting
Our Clients Speak
“While Evoltrace works with companies of all sizes, our consulting services are especially favored by our clients due to its unique pragmatic approach, which blends waterfall, agile, and mixed methodologies to optimize implementation processes, plus our attractive price-to-value offerings.”
Our Packages
Evoltrace Excelsis
Service tailored for small-sized organizations.
Evoltrace Excelsis +
Service tailored for small and medium-sized businesses (SMBs) and companies focused on growth.
Evoltrace Excelsis Pro
Service tailored for large-sized organizations with expansion plans.
General Consulting
We provide personalized services beyond our standard packages, tailored to meet your specific requirements.
