PHASE Compliance & Engineering Services. sell "COMPLIANCE"
Basic Information
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Category
Subcategory & Sub-subcategory
Trade Type
Sell
Service Name
COMPLIANCE
Details
Service Provider(s)
Specifications
- Application: Applied in biopharmaceutical development, manufacturing, or analytical support for biologic drug substances/products
- Certification Standard: Manufactured under cGMP with ISO 9001 quality management certification
- Regulatory Status: Registered/approved in accordance with applicable national regulatory requirements (e.g. FDA, EMA, WHO-listed authorities)
- Country of Origin: Multiple sourcing countries (per specific supplier)
Other Information
Additional Description:
PHA.SE supports clients across vendor auditing, commissioning of new systems, equipment and facilities, in-house testing using its own instrumentation to save time and cost, compliance and validation for both new and legacy systems, and computer system validation documentation for automated systems, all carried out following a GAMP-compliant approach aligned with international regulations such as 21 CFR Part 11.
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