Quality Systems
& Compliance
Based on Evolution
During years, most of ECONS working experience has been in the areas of quality and compliance in the Pharma, Biotech, Consumer and Medical Devices industries. We currently have over 25 resources assigned to quality systems, validation and compliance projects.
ECONS will help to manage quality and compliance initiatives as defined by the client and by regulatory agencies. Also, ECONS will facilitate the Q&C processes evaluation, the proper documentation is in place, roles and responsibilities are balanced and in the right area, and systematic tools are in place and working.
- Facilities & Utilities
- Manufacturing & Packaging Process/ Equipment
- Product/Process Transfer
- Computer Systems Validation (CSV)
- Cleaning Validation
- Lab equipment and method
- Supplier Quality Assessment
- Internal Audit Process
- Corrective and Preventive Actions Process
- Investigation Process Evaluation
- Technical/SOP Writing
- Risk Management
- Regulatory Submission Project Management
- Change and RA Action Assessment
- Document Gathering and Package Assembly
Specifically, in each of these areas, not only do we provide resources, but also consulting services to design, implement, govern and remediate these processes:
- Process Audit Programs Development and Execution
- Quality Systems assessment and improvement strategy development
- Master Validation Planning
- Quality Systems processes Assessment
- Metrics Systems Improvements, from Data Mining to Visualization & RC Analysis
- SOP & Batch Records Improvements
- Regulatory Submission End-to-End Process Development and Digitalization
We will help your company to understand and create strategies for the demanding complexity of the different Regulatory requirements in order to successfully sale your products in the specified markets and maximize value.
