Audit-ready from day one. Aquaterra weaves quality thinking into every experiment, batch, and byte—so your program sails through IND, IMPD, BLA, and MAA reviews.
Quick Facts
- 100 % electronic batch records (21 CFR Part 11 compliant)
- GMP / ISO 9001, 13485, 14644 certified QMS and cleanrooms
- 24/7 environmental monitoring with microbial and particle counts
- Embedded data-integrity framework across all labs and suites
Core Services & Workflow
- Quality Management System (QMS)
- Risk-based, ICH Q10 aligned covering SOPs, training, document control, deviations/CAPA, change control, supplier qualification, and recall readiness
- Live KPI dashboards for cycle times, trending, and audit preparedness
- Regulatory Strategy & Filing Support
- Gap analyses versus FDA, EMA, PMDA, NMPA, and WHO requirements
- Authoring or conversion of eCTD Modules 2 & 3, IMPD Quality sections, and Device Master Records
- Real-time collaboration in Veeva Vault or your chosen RIM platform
- CMC & Analytical Consulting
- Specification setting, reference-standard qualification, and comparability protocols
- Method validation/verification per ICH Q2(R2) draft and USP <1220>
- Stability-study design (ICH Q1A/E) with bracketing, matrixing, and statistical trending
- Computer Software Assurance (CSA)
- CSA-driven validation for MES, LIMS, PAT, and historian systems
- GAMP 5 risk assessments and living validation plans that scale with each software release
- Inspection & Audit Preparation
- Mock Pre-Approval Inspections (PAIs) and data-integrity drills led by ex-agency SMEs
- Interactive “war-room” playbooks, annotated floor plans, and live SME coaching
- Global Pharmacovigilance Linkage
- Safety-data exchange agreements, PSURs, and signal-management coordination
- Lifecycle Compliance & Post-Market Support
- Annual Product Reviews, continued process verification (CPV), and change-control dossiers
- Ongoing label/pack updates to meet evolving pharmacopeial, REACH, RoHS, and MDR requirements
Why Aquaterra?
- Regulatory Expertise – Experienced teams guide you through global filings and inspections.
- Data Integrity by Design – Instruments feed time-stamped, audit-trailed data to a Part 11 historian—no manual transcription, no shadow spreadsheets.
- Proactive Risk Management – ICH Q9 risk assessments and FMEAs at kickoff lower late-stage remediation costs by up to 50 %.
- Integrated Teams, Zero Silos – QA, QC, regulatory writers, and engineers resolve issues in hours, not weeks.
- Transparent Metrics – Client portal displays deviation trends, CAPA status, EM excursions, and batch genealogy in real time.