Services

Our Services

We understand that entering new markets requires more than just strategy; it demands precision in execution. We offer comprehensive services that include market analysis, entry strategy development, local partnership identification, and cross-cultural training to ensure seamless integration and sustainable growth.

International Market Expansion

Expanding into international markets can be challenging. Our experts can assist you in navigating the complexities of international quality requirements to help you successfully expand your business globally in an EU-GMP environment.

Quality Management Systems

We specialize in developing and implementing Quality Management Systems to enhance efficiency and ensure compliance with industry standards. Health Canada, FDA GMP. EU-GMP, ISO and ICH.

Compliance Support

We offer strategic planning and support including SOP writing, Validation Protocols and Execution, Pre-Audit reviews and Post-Audit response and corrective actions. Refer to List of Services for more complete listing.

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

Years of Experience

0 + Years

Cannabis Experience