For pharmaceutical, biotech, and medical device manufacturers, Quality Management Systems (QMS) is the foundation for enabling the organization to operate compliantly. The QMS establishes the path to compliance for the company and enables sustainable systems that meet the demands of regulators, customers, and ever-changing business environments.
Reliant’s consultants offer a full range in designing, building, and managing QMS programs.Our industry-leading experts understand the complex regulatory elements and the compliance systems required for your organization to succeed. We can help guide your team through the regulatory processes specific to your quality programs.
- Quality Culture assessment, education, and deployment
- Quality Risk Management program deployment
- Quality Metrics program deployment
- Data Integrity programs
- Regulatory submissions and strategy (510k, PMA, NDA, BLA, IND, IMPD, EU CP and DCP, etc.)
- Auditing (cGMP, QP Certification, Supplier, Internal, Process)
- EU Qualified Person services
- CMO capacity and feasibility analysis
- Compliance remediation
- GMP & ISO Quality Management System development, implementation, and improvement
- Standards assessments including gap analysis
- Supplier Quality Management program implementation
- Investigation and Root Cause Analysis program implementation
- Quality management review implementation
- Stability program development
- Permanent Inspection readiness programs
- Assistance with FDA and other Competent
- Authority meetings (requesting, preparing for, and conducting)
- Post Market Surveillance & Complaint
- Handling Services (MedWatch, Adverse Events, MDRs)
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