Pharmaceutical QA & Compliance
Audit-ready systems.
Regulatory precision.
Built for FDA, WHO, EMA and MHRA environments. Bugzyme delivers Computer System Validation, GxP, 21 CFR Part 11 and data-integrity programs that hold up under inspection.
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What is CSV?
Computer System Validation is the documented evidence that a regulated computer system performs as intended throughout its lifecycle — required under FDA 21 CFR Part 11 and EU Annex 11.
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What frameworks do we cover?
FDA, WHO, EMA, MHRA, ICH, GAMP 5, ISPE — applied operationally, not academically.
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How do we handle audits?
Pre-audit gap assessments, mock inspections, documentation remediation and on-site representation.
What We Deliver
Six service lines that span validation, regulatory affairs and resource placement.
- ▸CSV (Computer System Validation)
- ▸GxP Validation — IQ, OQ, PQ protocols
- ▸21 CFR Part 11 Compliance
- ▸Data Integrity Assessment & Controls
- ▸SOP Development, CAPA, Risk-Based Validation
- ▸Audit & Compliance Support
- ▸GMP & Regulatory Documentation
- ▸Greenfield and brownfield facility setup
- ▸Sterile and non-sterile facility design
- ▸QC & Microbiology laboratory qualification
- ▸Equipment procurement guidance
- ▸Lab automation and IT-enabled batch release
- ▸DMF & Dossier preparation (CTD/ACTD)
- ▸Regulatory strategy and gap analysis
- ▸Query response management
- ▸Competitor benchmarking
- ▸Digital & IT support for compliance
Qualified pharma professionals. On your site. On our payroll.
Bugzyme places experienced pharmaceutical QA professionals and compliance consultants directly at your facility — fully employed by Bugzyme, accountable to your site's standards.
- ▸Pharmaceutical manufacturers needing audit-ready QA teams without permanent headcount
- ▸CROs expanding capacity without long-term HR commitments
- ▸MedTech companies requiring temporary validation expertise
- QA ManagersSENIOR
- Validation EngineersSENIOR
- Regulatory Affairs SpecialistsSENIOR
- GMP Compliance OfficersSENIOR
- Data Integrity AuditorsSENIOR
- CSV ConsultantsSENIOR
- ▸GMP & compliance training programs
- ▸Audit preparedness workshops
- ▸Recruitment support for pharma QA roles
- ▸Merchant export services for pharmaceutical products
- ▸Regulatory compliance for global markets
Have a release coming up — or an audit?
Onboard with a senior team in under 72 hours.