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Quality & Compliance Solutions for the Life Science Industry

Risk Assessment & Management,  Compliance to ICH E6 (R2)

Quality & Compliance frameworks for Start Ups

Vendor assessment and vendor oversight 

Operating Models / Business Process Development for start ups

Inspection Readiness (training & mock audits)

Contact DArcy Consulting

Please contact us at your convenience for an initial consultation. We look forward to hearing from you.

​Call Today: (610) 241-6983

Staff Augmentation/ Project management Support

Our services are totally wrapped around making our Start Up clients successful. For Life Science Start Ups, we offer services around Gap Assessments, Development of SOPs, Development of Quality, GCP and GMP Training (curricula & roll out), Inspection Readiness activities  as well as project management to support the services listed. Because of the high quality work, we have been retained not only by Quality and Clinical functions but also extensively by Regulatory and PV functions, particularly in the area of SOP writing.

For some clients, we have become their defacto QA function helping to write SOPs, driving development & roll out of training, getting vendor agreements in place, conducting vendor / site audits as well as supporting implementation of electronic quality management systems.

 GCP/ GMP/ GLP/ GDP training

Corporate compliance programs for Start ups

SOP (GCP, GMP, GLP etc.)

Clinical Compliance  Gap Assessment

DArcy-Consulting

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