Good Manufacturing Practices (GMP) Service Offerings  Auditing:   GMP – GMP facility audit to FDA requirements GTP – Tissue engineering, cell therapy and tissue bank audits Internal audit system development    Evaluation of Sponsor and Contract Clinical Supply Operations QA/QC system evaluations Product complaint investigations Labeling Storage and distribution GMP record and report requirements Regulatory agency audit response formulation and remediation:  (PMA, PAI, 483, Consent decree, Recalls, Warning Letters and Market withdrawals, etc.)   Quality systems assessment, risk, assessment, design and implementation; Needs/Gap analysis   Process and scale-up validation   Equipment Qualification/Validation   Computer validation   Facility design   Environmental monitoring   Utility and facility design and monitoring   Management strategies for compliance systems   Training of employees to GLP’s/GMP’s; Beginner, Intermediate, Advanced levels; Group or individual   Quality systems integration and harmonization: For difficult, combination products and/or multiple quality systems requirements   Vendor and supplier audits – GLP/GMP vendor qualification   Documentation and batch record systems development   Review and development of SOP’s   21 CFR Part 11 compliance   CAPA/Deviation systems development   Stability Program implementation   GMP Regulatory Service Offerings:   Regulatory filing preparation and filing   IND NDA ANDA 510(k) PCA   Recall, Adverse Event and Complaint systems implementation