Recognizing that not every company requires a full-time quality professional, we offer fractional quality assurance services tailored to your needs. Ideal for small to medium-sized businesses with varying operational demands. We work with your schedule and budget to determine your customized needs.

Is there a business opportunity with another license holder, supplier or manufacturer, but you don’t know if they’re following high operational standards you need to give you piece of mind? That’s where Merit Method comes in. We will audit the prospective supplier and provide you with the intel you need to make the right decision for your business.

Our expert team of regulatory specialists conducts thorough reviews of product labels, packaging materials, and accompanying documentation to ensure compliance with relevant regulations and guidelines. This includes compliance checks to meet FDA, EMA, Health Canada and other authorities, graphic design review and risk assessments.

We offer a full suite of validation services to meet Health Canada, FDA, ICH and many European Standards to include:

• Process Validation and Validation Master Plan

• Warehouse Validation

• Cold/Wet/Dry Room Validation

• Refrigerator/Freezer Validation

• Incubator and Oven Validation

• Laboratory Instrument and Equipment Validation

• Computerized System Validation

We offer process validation services for EU-GMP to confirm through documented evidence that your manufacturing processes consistently produce a product to meet pre-determined quality attributes. This includes process design, process qualification, and continued process verification.  This rigorous validation process ensures your processes comply with EU-GMP regulations guaranteeing the safety, quality and efficacy of the medicinal product.

EU-GMP standards require that equipment be verified that they function as per their intended use and performing consistently.  The qualification includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)