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Brianna Novaris Email
Engineering Manager, Validation and Manufacturing . Compliance Group
Libertyville, IL
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130Revenue:
$15.6MAbout
Compliance Group is a Quality Compliance solutions provider based in Illinois, US with offices in the UK and India. Compliance Group's motto is to provide right-sized compliance solutions. Compliance Group is run by a team who are at the cutting edge of developments in Compliance - we are actively working with FDA consortium that aims for a paradigm shift in guidance for the industry. This knowledge & expertise has resulted in significant capital and operational savings for our clients. With onsite/offshore delivery models and presence in US/EU & India, Compliance Group has proven expertise supporting customers with the following: - On-Premise or SaaS Quality System offerings - Setting up QMS and SQA policies - Center of Excellence (CoE) - Setting up and running CoE models using Onsite/Offshore delivery models - Support with Computer System Validation, Process Validation, Equipment Validation, Cleaning Validation, Medical Device product validation & Quality Engineering (CAPAs, NCRs, Complaints, Supplier Quality execution) - Audit/Inspection Readiness Assessments - If there is an impending Internal Audit or an External Regulatory Agency Inspection, we can perform Audit Readiness Assessments and deliver prioritized remediation activities - Supplier Quality Audits - Our certified Auditors can perform Supplier Quality audits and provide intelligence on Supplier Quality. - Remediation Packages - Packages to address Consent Decrees, 483s, Warning Letters and Data Integrity Issues - Process Improvement Packages - Clinical Trial Development Support - Biostatistics, Data Analytics & Statistical Programming from Development to Regulatory Submissions - Serialization/UDI - Setup & end to end line validation/compliance With "right-sized" solutions, cost-saving recommendations from FDA consortiums, rapid scalability & competitive pricing - Compliance Group is a world leader in providing solutions to Life Sciences companies.Compliance Group Address
1512 Artaius PkwyLibertyville, IL
United States