Quality Assurance Consultancy
We understand the importance of quality in the Pharmaceutical and Medical Device industry. Our Quality Assurance, Quality Engineering, Software Quality, Design Assurance and Quality Compliance experts work closely with our clients to develop robust Quality Management Systems that ensure compliance with Regulatory requirements while optimizing Product Quality, Risk and Safety. We help clients ensure Compliance with Regulatory requirements through Quality Management systems, Audits, and Inspections. Our team provides support for quality system development and implementation, as well as assistance with Regulatory audits and Inspections.
Quality Management System Development
o Medical Devices (ISO13485 and 21 CFR part 820)
▪ Quality Manual
▪ Quality policy
▪ Standard Operating Procedures (SOPs)
▪ Work Instructions (WIs)
▪ Forms/Records
o Drugs & Biologicals
▪ Quality Manual
▪ Quality policy
▪ Standard Operating Procedures (SOPs)
▪ Work Instructions (WIs)
▪ Forms/Records
Document Development & Review
o Medical Devices
▪ DHF Development
▪ Trace Matrix development
▪ Risk Management Files
▪ Validation documents
▪ Biocompatibility documents
▪ Shelf-life
▪ Packaging Validation
▪ Process Validation
▪ Cleanroom Validation
▪ Sterilization Validation
▪ Software Validation
▪ Human Factors/ Usability Engineering Validation
▪ Labeling Verification & Validation
▪ Product Development Process- Design Controls
o Drug & Biologicals
▪ Quality by Design (QbD) protocols and reports
▪ Batch Manufacturing records/Batch Process records, Batch Packing records
▪ Master Manufacturing documents
▪ Process Validation, Sterilization validation Document Support
▪ Analytical Method Development & Validation
▪ Stability studies and Shelf-Life Determination
Trainings
o Medical Devices
▪ ISO 13485: 2016
▪ 21 CFR 820
▪ Q-SIT inspections
▪ Risk Management
▪ Design Controls
▪ CAPA's
▪ MDRs
▪ UKCA Certification
▪ FMEAs
o Drugs & Biologicals
▪ 21CFR part 210 & 211
▪ FDA inspections
▪ CAPA's
▪ Risk Management