Regulatory and Compliance
How we do it
Regulations and compliance were put in place to ensure companies act responsibly. At MAS Connections our comprehensive approach and assessment of compliance gaps, mock audits and reviews of the regulated areas, allows us to generate recommendations and best practices, according to the nature and specific characteristics of each organization.
During her twenty years in the industry Adriana Rozo-Angulo has developed experience and understanding of the knowledge needed to address different compliance issues and allow her to promptly identify risk areas. The process starts by finding the gaps and plan the work needed to bring your company into compliance.
OUR SERVICES INCLUDE:
- Compliance review and gap analysis of FDA & ISO 1901 & 13485 regulations.
- Develop of QMS Compliance/Quality plans.
- Process documentation – Standard Operating Procedures (SOPs)
- Validations (FAT, IQ, PQ, OQ)
- FDA & ISO audits readiness.