Quality Services

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• Pharmaceuticals (Large and Small Scale) (Sterile injectable and solid oral dose)
• Biotechnology
• Therapeutics
• Medical Device (Vascular products, Diabetes care, Wearable device, Diagnostics, etc.)
•  Consumer Goods
• Cosmetics
• Personal Care
• Healthcare Products

Our group of partners are experienced in assessing regulatory requirements for most types of Life Science or Consumer Goods businesses (e.g., Pharmaceutical, Biotechnology, Medical Device, Nutrition, Nutraceuticals, Diagnostics, etc.).  

We have a proven track record for ensuring organizations meet and exceed the expectations of applicable regulators.  Services include assessment of applicable Regulations and Guidance documents, assessment of Organizational Policies and Procedures, Validation, Inspection Readiness Activities and Training, and implementation of remediation activities.   

Our team has real world experience supporting organizations on across the globe gain approval for their products from the FDA as well as local regulatory bodies including Health Canada, COFEPRIS, EMA, ANVISA, TGA, WHO, ISO, etc.)

Development of a comprehensive Quality Oversight Strategy is essential to any business.  We understand that business interruptions and product backlogs can quickly diminish the customer base you have worked to diligently to build.  Our partners have experience implementing oversight models that are simple to implement, easy to follow and give the organization indications of key indicators which can potentially hinder their product pipeline.     

Our experienced partners have worked around the globe assessing, implementing and remediating Quality Management Systems for organizations of varying complexity across the Life Sciences industry. This experience makes us uniquely qualified to help design a QMS which is aligned with the current state of the organization, but also with the forethought and flexibility to grow and adapt to future requirements.  We have experience with various types of Quality Management System Software and Analytic Models to support your organization, including: Veeva, MasterControl, TrackWise, Qualio, etc.. 

We have experience working with a variety of vendors, including Contract Manufacturing and Development Organizations (CDMOs), Contract Research Organizations (CROs), Investigator Sites, Computer System Developers, Raw Material, Component and Packaging Suppliers, and Testing Laboratories.  

We have aided many organizations in the building out of Supplier Qualification and Management processes and procedures, including Quality Agreements, Vendor Checklist, Audit Report Templates and Change Assessment.   Our partners are experts at sourcing, assessing and qualifying new vendors based upon customer needs, expectations and applicable regulatory requirements.     

• Establishment of Testing Specification  
• QC Laboratory Sourcing 
• Product Stability 
• Retains Management 
• Product Disposition/Batch Release
• Product Quality Investigation