How We Support Quality & Compliance Teams
Our services are designed to meet clients where they are, whether building quality systems from the ground up, preparing for an upcoming inspection, responding to regulatory findings, or strengthening existing compliance programs to match current growth. We provide practical, stage-appropriate, hands-on support that integrates seamlessly with your internal teams.
Quality Systems & Program Development
Designing, building, and maintaining compliant quality systems.
- Quality Planning
- Quality Program Assessment
- Quality Assurance Program
- Quality Manual Development
- Standard Operating Procedure (SOP) Development
- Specification Development
- Corrective and Preventive Action (CAPA) Program
- Document and Change Control Program
- Personnel Training and Development Program
- Data Integrity Assurance
- Quality Control Method Development Guidance and Support
Audit, Inspection & Compliance Readiness
Preparing teams for regulatory inspections and audits
- Inspection Preparedness
- Executive Management Quality Reviews
- Internal and Supplier Audit Program Implementation
- Quality Unit Auditing (ISO, QSR, GMP, MDR, IVDR, CMDR, MDSAP, CMDCAS)
- Due Diligence Auditing
- Data and Submission Auditing
- Clinical Quality Auditing
Operations Development
Designing, building, and maintaining operations programs.
- Material Management System
- Validation Program Development and Implementation
- Utility and Equipment Qualification
- Batch Record Development
- Equipment / Instrument Calibration and Maintenance Program
- Environmental Control and Aseptic Processing Program
- Facility Safety Program
Regulatory and Ongoing Support
Regulatory guidance and ongoing support.
- Regulatory Submission Strategy Support
- Technical Writing
- Quality and Compliance Project Management
A trusted partner supporting life science organizations through complex quality and compliance challenges.
TM Quality Consultants have a thorough knowledge of US and International regulations for drug, device, biologics, HCT/P, and HCT/P ancillary products.
This knowledge base has led to successfully achieving two (2) first time and six (6) repeat notified body certifications (MDD/MDR, IVDD/IVDR, CMDCAS, MDSAP, SOR/98-282, ISO 13485, ISO 14971 & ISO 9001), successfully maintaining quality systems during surveillance years and successfully managing eight (8) FDA inspections including two (2) pre-approval inspections. In addition to core regulations and standards, there is a working knowledge of multiple guidances, standards and regulations from FDA, ISO, ASTM, USP, AABB, AATB and FACT.
Business CV available upon request with NDA/CDA
Supporting Life Science Industries Globally
- Human Cells, Tissues, and Cellular and Tissue Based Products (Advanced Therapy Medicinal Products)
- Pharmaceutical Products
- Medical Device Products
- In Vitro Diagnostic Products
- Clinical Research Organizations
- Contract Manufacturing Organizations
- Ancillary HCT/P Material Producers
TM Quality Control, LLC 