Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20WHAT WE DO HOW WE DO IT REMEDIATION INSPECTION PREPARATION FDA NEGOTIATIONS FDA FORM 483 / WARNING LETTER RESPONSES CONSENT DECREE STRATEGY/ EXECUTION PROCESS VALIDATION CLEANING VALIDATION COMPUTER VALIDATION METHOD VALIDATION DATA INTEGRITY CLINICAL ASEPTIC PROCESSING SOLID DOSAGE BIOTECH VACCINES MEDICAL DEVICE REGULATORY COMPLIANCE ANALYTICAL CHEMISTRY MICROBIOLOGY STERILITY ASSURANCE ENGINEERING OPERATIONS AREAS OF TECHNICAL AND REGULATORY EXPERTISE INCLUDE: A QxP INNOVATION THAT • Quickly identifies the issues that matter • Systematically works through these issues using a risk-based approach to create pragmatic solutions • Ultimately delivers long-term meaningful solutions R.A.C.E. ONLY REAL EDUCATION BRINGS REAL RESULTS Our “Teach & Do” approach ensures that knowledge is transferred and that change can be sustained over the long term. A E C R E X E C U T E CONSOLIDATE A S S E S S REVIEW