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Quality Management & Compliance

We provide services across a company’s life cycle from helping emerging companies set-up quality systems and generate SOPs to assisting mature companies review batch records, audit suppliers and manage consent decrees.
When a biopharmaceutical, medical device or diagnostics company needs a QA consultant, it’s usually for one of two reasons. Either they need someone who can provide high-level leadership and guidance in establishing the company’s QA practices from the ground up or they need someone who can step in to supplement existing staff during busy times. We at Complya – a PharmaLex page address both types of needs. Our roster of consultants ranges from strong mid-level talent to some of the highest skilled, senior-level talent in the industry. Our goal: match your needs with the right person for the job.

GxP services:

Strategic Support

► Develop phase appropriate Quality System
► Gap Analysis and Remediation and Implementation
► Pre-Approval Inspection Readiness (Mock PAI Audit)
► Warning Letter and Consent Decree Remediation

Operational Support

► Batch Record and Validation Review
► GMP Training
► Supplier and Internal Audits
► Deviation and CAPA Remediation
► SOP Generation
► Document Control
► Interim support (Junior through Senior level roles)