01
For processes, systems and plants. Assessment of compliance with GMP (FDA, EMEA, ANMAT, ANVISA, INVIMA and others).
- Regulatory Audits
- Compliance and follow-up audits
- Gap analysis part 11
- Improvement plans
- Follow-up of current, on-going plans
- Process improvement
02
Support and project management. From the planning to the delivery of work, were main with your project.
- Pre-construction management
- Planning, construction, management
- Quality assurance, cost, control equipment acquisition
- Start-up of systems and equipments
- HVAC Sytems: development, design, implementation, electrical installation, calibration, start-up
03
Development, design, implementation and supervision.
- Development of procedures for: systems, areas, equipment and maintenance
04
Every automation requirement is unique and so are our solutions. We have the ability and knowledge to create programs from scratch and to modify and extend existing ones.
- Automation Project Management
- Commissioning of automated systems
- PLC Programming Systems
- SCADA Programming Systems
- Development and execution of automated processes and computerized systems protocols (validation plans/IQ/OQ/CSV/PQ and reports)
05
Implementation of improvements to achieve more effective results. Troubleshooting and optimization towards efficiency.
- Process control improvements
- Audits and assessment GAMP5
- Plant Control Systems Support (problem solving, emergency calls)
06
With international experience in law and business, we provide consultation services regarding the decisions and paperwork required to complete the project.
- Analysis, mediation and viability studies for the purchase and sale of establishments, products, and/or equipment between different countries
- Registration of products in different countries under local regulations
- Negotiation and mediation between parties
- Facilitate registration and/or patent services in the US market
- Preparation and submission of Interim New DrugApplications (IND), New Drug Applications (NDAs), and supplemental New Drug Applications (sNDAs)
- Continuity plans
07
Implementation and improvement. Troubleshooting and optimization toward efficiency. We provide the necessary support with the appropriate knowledge to comply with all requirements.
- Assessment before a product or technology transfer
- Support in the preparation of transfer documents
- Troubleshooting during manufacturing
- Investigations
- Cleaning procedures
- Design and area classification
- Selection of equipment and systems design
