PHARMACEUTICAL
Pharmaceutical GMP training and mentorship
Specialised in aseptic cleanroom manufacturing
Design and set up of large scale manufacturing sites in line with global cGMP regulations, including FDA, EMA, MHRA.
Regulatory consultancy & license submission, including preparation of regulatory dossiers and submission to competent authorities.
Preparation for regulatory, competent authority inspections, specialised in FDA, MHRA & EMA inspections
Performance of worldwide audits and mock inspections in line with global regulatory requirements, eg. FDA
Validation Engineering for facilities, utilities, equipment, analytical methods, cleaning and computerised systems (FDA 21 CFR part 11 & GAMP 5)
Quality Management System Implementation
Need help with inspections and launching Medical Devices
