Our Services
We understand that being a start-up or entering a new market requires more than just strategy; it demands precision in execution. We offer comprehensive services that include compliance guidance and cross-cultural training to ensure seamless integration and sustainable growth.
Why Choose Us
Our commitment to quality management ensures that our clients maintain the highest standards of excellence as they expand. We provide tailored quality assurance programs, process optimization, and compliance solutions that align with international standards and best practices. By leveraging our expertise, businesses can achieve operational efficiency, reduce risks, and enhance customer satisfaction.
We provide consulting services encompassing all aspects of Quality Management Systems (QMS), Quality Assurance, and Compliance for GMP facilities, including assistance with EU-GMP compliance within the pharmaceutical and medical cannabis industries
Pre-Audit Inspections and QMS GAP Analyses
Guidance on international regulatory agencies for Germany and Australia
Support for Internal and External Audits
Support for Deviation, CAPA, Risk Assessment, and Complaint Investigations
Document SOP and Batch Record writing as well as process development
Validation and Qualification protocol writing and execution support
21 CFR Part 210 and 211 - GMP 21 CFR Part 11 - Validation
Cannabis Experience
ISO Standards
ISO 9000 - Quality Management System in Production Environment
ISO 9001 - Quality Management
ISO 14000 - Environment Management Standards in Production Environment
ISO 14001 - Environmental Management
ISO 14644 - Standards Cleanrooms & Associated Controlled Environments
Plus Australia Medical Cannabis TGO 93
ICH Guidelines
Q1A - Q1F - Stability
Q2 - Analytical Validation
Q7 - Good Manufacturing Practice
Q1A - Q1F - Stability
Q9 - Quality Risk Management
Q1A - Q1F - Stability
Q10 - Pharmaceutical Quality System
Ready To Get Started?
