➢  Remediation / Regulatory Response

o Form 483 Response

o Warning Letter Response

➢ GXP AUDITING

o Clinical Facility/Laboratory Auditing

o Quality Control Laboratory Auditing

o Raw Material Supplier Qualification

o Contract Manufacturing Organization Compliance

o Internal Audits (Quality Systems Assessment)

➢ Compliance Gap Assessment for Quality Systems

o Production

o Facilities & Equipment

o Laboratory Controls

o Materials System

o Packaging & Labeling

o Quality

➢ GMP Facility Build Out Design & Planning

➢ Environmental Monitoring Plan Development

➢ Person in Plant Representation

➢ cGMP Training

o New Employee Training

o Focused Training (Specified Topics)

o Refresher Training

➢ Document Control System—Implementation & Maintenance

.9999 If you are interested in learning more about our services,  please contact us through email or telephone.