Services

Ensure compliance with detailed quality audits for seamless operations.

• Internal Audit
• Gap Assessment
• Audit Report Drafting
• Facility Assessment

Develop robust strategies to manage and mitigate operational risks.

• Cleaning validation risk assessment using FMEA.
• Cross-contamination risk in multi-product facilities (as per ICH Q9)
• Supplier Qualification risk matrix
• Ingredient safety assessment per Health Canada and FDA guidelines

Licensing:

We offer specialized licensing services to help businesses comply with regulatory requirements across various industries. Our services include applying for Drug Establishment Licenses (DEL), Natural Health Product (NHP) licenses, MoCRA registration for cosmetics, FDA registration, CARES Act Amount Information Reporting, and business licenses. We simplify the complex licensing process, ensuring your business meets all necessary regulations so you can focus on growth.

Regulatory:

• FEI number Registration
• DUNS registration
• MoCRA Registration
• CARES Act Amount Information Reporting
• Drafting Responses for Health Canada and FDA Audits observations
• Corrective and Preventive Actions (CAPA)

Enhance efficiency with tailored process optimization solutions.

We offer comprehensive support in the following areas:

Investigation of:

Out-of-Specification (OOS) results
Deviations
Change Controls
Customer Complaints
Product Recalls
Laboratory Investigation Reports

Documentation and Compliance:

Standard Operating Procedures (SOPs) – writing and review
Validation Protocols – development and execution
Validation Reports – preparation and summary
Our services ensure full regulatory compliance while upholding the highest standards of product quality.

Evaluate and ensure the quality of suppliers with thorough assessments. and qualifications.

• Supplier Qualification & Evaluation
• Supplier Risk Assessment
• Technical/Quality Agreements Review
• Drafting and reviewing Quality Technical Agreements (QTAs)
• Defining roles and responsibilities clearly between parties.

At Compliance Xpert Solutions, we offer comprehensive training programs designed to enhance your team’s understanding and implementation of key quality and regulatory standards. Our sessions are practical, industry-relevant, and tailored to meet regulatory expectations.

• GMP Training (Good Manufacturing Practices)
• GDP Training (Good Documentation Practices)
• GLP Training (Good Laboratory Practices)
• Data Integrity Training
• Audit Readiness & Inspection Training
• Customized In-House or Virtual Training