PROFESSIONAL SERVICE
Quality Compliance and Process Improvement
Regulated processes. Is it possible to be profitable?
The rate of change imposed by the market today, the rapid technological transformation that supports increasingly productive processes, the use of more sensitive detection systems, and high staff turnover, make every day we add one more risk factors where we operate.
This is where we can help by giving support, preparing your support cases, exploring borders of regulatory requirements, auditing, looking for improvement no just fulfilling requirements, helping with authorities' approach strategy, improving time to market ratio, detecting knowledge gaps and developing a comprehensive support plan.
We know it is important to give answers in a timely manner,
We know how to help!
Regulatory Affairs
Usual Regulatory
Legislation fulfillment
- Diagnosis: Delivering a report with deviations and possible solutions.
- Development of regulatory documents.
- Assistance in obtaining licenses and authorization of products.
- Monitoring and execution of projects.
- National and international assistance.
- Visible results post consultancy
GOVERNMENT AFFAIRS
Ethic and efficient follow up
We offer consulting services for companies and organizations to establish management processes in the political-governmental sphere and institutional positioning, maintaining loyal and transparent relationships, taking care of ethics in each of the steps of our clients' approach to the regulatory world.
Strategies paths development, regulatory monitoring, and follow-up of activities, especially for those clients who do not have specialists or do not have a consolidated network of contacts.
Through representation, we offer the possibility of putting together projects, executing the corresponding procedures, and having the direct representation of interests before the Public administration.
Strategy definition
Analysis, planning and Implementation
- Understand current position
- Map stakeholders (analysis)
- Analyze business environment
- Identify and evaluate options
- Outline steps to go there
- Communicate strategy
Assistance in obtaining licenses and authorizations, pharmacovigilance, and regulatory strategy design.
Processes
Audit / Processes Review / Agile Methodology
Pre audit or Process improvement: A tool to understand
In our audits we not only detect non-conformities, but we also train staff, we do not stay with the observation, we look for patterns and with these findings, we propose solutions.
One of the key aspects of a sprint review is the feedback loop. Agile methodology emphasizes the importance of getting feedback early and often to ensure that the work being carried out aligns with customer needs.
Process/ Documentation Development
Standards, corporative norms or regulations needs
The adoption of a quality system is a strategic decision to improve performance and from that point grow in a "robust" way.
It ensures the organization's ability to provide products that meet the requirements demanded in the market.
Implementing a quality system connects business processes with current and potential market needs.
Training
Stay prepared
- Assess Compliance
- Quality Management
- Quality Engineering
- Risk Management
The objective of maintaining compliance and accelerate the response time of the authorities.
We can assist your company!