Sigma Analytical is dedicated to providing of comprehensive training and consulting services, tailored to meet your every need.
Our team of experienced scientists and technicians has the expertise to provide support in a wide range of areas, including but not limited to:

• Method Development and ICH and USP Validation
• Method Verification
• Method Transfer
• Method Optimization
• Staff GMP and ISO Training
• In-house Lab Set up
• Conducting Internal Audits and Assisting in Supplier Qualifications
• Cleaning Validation and Disinfectant Efficacy Studies
• Process Validation
• Attending and Supporting Regulatory Audits, as well as Assistance with Audit Responses and Addressing Regulatory Findings.
• QMS (Quality Management System) in box and SOPs Development
• Quality system Design, Development and Establishment
• Quality System Gap Analysis and Gap Closure
• Regulatory Submissions, such as Drug and Device Registration
• Assistance with establishing quality systems in compliance with desired and required regulations from different jurisdictions such as EU GMP, cGMP, Health Canada GMP.
• Assistance with applying for and obtaining various licences and certificates such as Drug Establishment Licence, ISO 17025, ISO 13485 (Medical Devices) and MDSAP (Medical Device Single Audit Program), Cannabis Processing, Analytical Testing and Research Licence, and Dealer’s Licence for Controlled Substances and Australian GMP.
• Equipment Performance Qualification

By leveraging Sigma’s knowledge and experience, you can ensure that your products are brought to life and safely brought to market. Our goal is to provide you with the tools and resources you need to achieve your business objectives and meet the highest standards of quality and safety

Bring Your Product to Life and Safely to Market with Sigma’s Support and Expertise in Quality Assurance and Testing.

Contact Sigma today to discuss your specific needs and learn how our training and consulting services can support your business.