Quality Management System
Quality manual, quality policy, management review procedures, internal audit programme and change control framework.
Quality ManualChange ControlDeviations
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GxP Documentation
Writing, reviewing and optimising pharmaceutical documentation to meet WHO, FDA, EMA and ANVISA expectations.
WHO · FDA · EMA · ANVISA
Seven Document Families
ALCOA+ Aligned
Overview
Documentation That Survives Inspection
Inspectors do not audit your intentions — they audit your documents. We write, restructure and remediate the documentation set that carries your quality system, from the quality manual down to individual batch records.
Every document is drafted for a specific product type and a specific target market, because a dossier that satisfies WHO prequalification is not automatically the one that satisfies an EU competent authority.
At a Glance
- Writing documents from scratch
- Reviewing & improving existing SOPs
- WHO, FDA, EMA and ANVISA alignment
Need this scoped for your facility and target market? A senior consultant will give you a candid read at no cost.
Request a ProposalWhat We Deliver
Four modes of engagement, depending on where your documentation stands today.
- Writing documents from scratch — Complete authoring for new facilities, new product lines or first-time market entry.
- Reviewing & improving existing SOPs — Gap review against current regulation, then rewriting for clarity, consistency and enforceability.
- Regulatory compliance assurance — Verification that content, format and cross-references satisfy the target authority.
- Tailored for product type & target market — Documentation shaped around your dosage form, process and destination market.
Document Categories We Cover
Seven families spanning the full quality documentation hierarchy.
Standard Operating Procedures
Operational procedures across production, quality, engineering, warehouse and laboratory functions.
AuthoringReviewPeriodic Revision
Production & Batch Records
Master batch records, batch manufacturing records, packaging records and in-process control sheets.
MBRBMRBPR
Quality Control Documents
Specifications, analytical methods, test procedures, stability protocols and OOS/OOT handling.
SpecificationsMethodsStability
Regulatory & Compliance
Site master file, validation master plan, product quality reviews and regulatory correspondence.
SMFVMPPQR
Training & Personnel
Training matrices, job descriptions, competency assessments and qualification records.
Training MatrixCompetency
Facility & Engineering
Equipment logs, maintenance procedures, calibration schedules and utility qualification documents.
CalibrationMaintenanceUtilities
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Book a no-obligation consultation and get practical answers about gxp documentation for your specific product, facility and target market.