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.