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)
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