Providing consulting and project management for the development, design, validation and manufacture of pharmaceuticals and medical devices. Areas of expertise include:

·      Process development, validation and quality engineering

·      Medical device design and quality system development  per ISO 13485:2003

·      Risk Management per ISO 14971:2007

·      Design and Process Risk Evaluation (DFMEA/PFMEA)

·      Compilation of Technical Files for CE Mark Certification

·      Management of contract manufacturing

·      Cleanroom design, startup and validation

·      Equipment procurement and validation