Services we provide

Quality Management Systems (QMS)        Establish, Manage and/or change QMS. Data Management and validation of  eQMS e.g. MasterControl, Trackwise 

Internal & External Audits                     Regulatory Authorities, Notified Bodies , Internal and External -CMO, CRO, Supplier.

Global Quality Management & Training   Leadership, Management Process Improvement, Systems, Training , Customer, Risk Management

Quality Assurance (QA)       Product Release, Document     Management, Complaints,   Change Control, Quality   Control (QC) , GLP, GCP   

Product Development, Design, Control            Product/Software Validation, Specifications, Packaging, labelling     

Covid related compliance  Protective Protective Equipment (PPE) ,            Medical Device Regulations 

Global Product Registraton                             Pharmaceutical (PO,OTC,Complementary)

Device (MDR & IVD, Class 1-III)         

Global Regulatory Strategy                                 Start-Up                            Market Access                  Business Transformation,        Import/Export

Global Clinical Trial Management                           CTX,CTN 

Post-Market  Surveillance                Recalls,  Marketing and Advertising

Audits                      ISO13485, ISO9001, FDA 21 CFR  Part 820 & part 11,  UL, PIC/S, IVD, MDSAP, GMP, Japan  GMP

Business Transformation   Mergers/Acquisition, Change Management, Post-Brexit strategy and management

Start-Up                            Start-up Strategy and Implementation from  Concept to Market

Training Management      Establish Employee Training and Monitoring. Includes employee Induction. 

Research (University/Company)  Product design & transfer from laboratory to clinical trials and market.

Health & Safety Management                     NSW, Return to Work Co-ordinator . Audits. Management and Systems

 GMP                                   Sterile Manufacture, Radio-pharmaceuticals, Medical Devices, Pharmaceuticals, Complementary Medicines.

 Facility upgrade            Facility validation, environmental controls, process controls and cleaning validation                                     

 Manufacturing & Supply Chain Management           Logistics, Cold-Chain, Warehouse, Sales & Distribution  

Equipment Qualification Verification, Validation, Calibration and Maintenance.

Product Transfer         Small scale to Manufacture> Design transfer from site to site (local and/or global)

Personnel Training              Management, Monitoring, Training