CONSULTING SERVICES

PAL provides consulting services for biotech, Pharma, Medical Devices and 503A & B compounding pharmacies. PAL Sr. consultant, Juan Munoz, has over 30 years of experience in the BioPharma industry in the areas of GxP quality systems, compliance, aseptic processing, environmental monitoring, microbiology, QC and validation. We can provide consulting services in English and Spanish. Our consulting services include:

⦁ Vendor GMP audits
⦁ In-house GMP audits
⦁ Clean room design
⦁ Environmental monitoring program design
⦁ CAPA investigations for sterility failures, EM failures, and product microbiology failures.
⦁ Evaluation of rapid microbiology systems
⦁ Medical device sterilization
⦁ Contamination control program design and implementation for aseptic areas and compounding pharmacies
⦁ Clean room validation HVAC, compressed gases and water validation protocol design
⦁ SOP preparation