Increase the Quality and Compliance level of Your Business & Gain an Edge Over Your Competitors
Our approach ensures that your site(s) can meet applicable standards and guidelines in compliance with regulatory requirements (Health Canada, FDA, EMA, ANSM, and ANVISA).
Quality Assurance and Regulatory Compliance
Our experts in quality assurance and compliance offer assistance in quality system implementation or remediation, including responding to Health Authority Inspection Observations and Warning Letters.
We also have personnel that can assist you with your daily QA operations, such as:
Quality Manual
Deviations / CAPA / Change Controls
Product Release
Annual Quality Product Reviews
Risk Assessments
Data Integrity Assessments
SOPs / Working Instructions / Forms
Batch Record Review & Simplification
Internal & External Audits / Mock Inspections
Quality Complaints / Mock Recalls
Drug Establishment License Amendments & Renewals
Project Management
Our experts will support you with your production and compliance projects from planning to completion. We integrate a lean and risk management approach at all stages of the process to ensure that compliance risk is managed effectively and proactively.
Supplier Evaluation and Auditing
We provide assistance in the evaluation and qualification of your suppliers. We perform assessments and site audits for raw materials, active pharmaceutical ingredients, packaging components, and contract services (manufacturing, packaging, testing, distributing, and calibrating). We have qualified auditors in Canada, the USA, and Europe. We can also implement quality agreements with your key suppliers.
Qualification and Validation
Our validation experts will participate in the qualification and validation activities from the validation master plan, protocol issuance, and data collection to writing reports for analytical methods, cleaning, computer, equipment, facilities, processes, and utilities, as required by you.
Customized Training & Professional Life Coaching
We offer detailed and interactive training in GMP, GDP, human errors, investigation techniques, and inspection readiness.
Our coaching prioritizes the human element of compliance, providing employees and management with the personal tools to work and lead with confidence and maintain peak performance without compromising their well-being.
Connect with us today for more information.