Complya Consulting Group, LLC

Complya Consulting Group provides QA and Regulatory Affairs consulting services to Biotech, Pharmaceutical, and Medical Device companies. Complya is focused on delivering measurable results - not on making your 'to do' list longer. We will roll up...

Complya Consulting Group provides QA and Regulatory Affairs consulting services to Biotech, Pharmaceutical, and Medical Device companies. Complya is focused on delivering measurable results - not on making your 'to do' list longer. We will roll up our sleeves to help you remediate gaps in your FDA or EMA compliance programs. We can function as an "extra set of hands" to help shorten your GMP/GLP/GCP to do list by: - Performing GXP Supplier Audits - Reviewing Batch Records and Validation Protocols - Writing and Revising SOPs - Helping to resolve a backlog of Deviations, CAPAs, etc. We can also assist with Regulatory Affairs consulting projects, including assisting with filings, annual reports, updates, and tech transfer issues. Our team of 25+ consultants work with companies at all phases of development (and commercial manufacturing), whether fully virtual or manufacturing in-house. Please contact us to learn more; we'd love to help out!