Quality System
Built for Compliance and Reliability
Quality by Design, validated methods, and electronic batch records underpin every project. Our teams engage early to lock critical quality attributes and process controls.
FDA Registered Facilities
Inspected sites with compliant controls
cGMP Manufacturing
Clinical through commercial batches
ISO 9001:2015
Documented QMS and continuous improvement
Data Integrity
Electronic records and traceability
QA & QC Framework
- Quality governance: SOPs, change control, deviations, CAPA, and audit readiness
- Analytical excellence: Method development/validation, stability studies, release testing
- Process controls: In-process monitoring for particle size, moisture, density, and content uniformity
- Documentation: Complete batch records, CoAs, and traceability for every lot
Validation & Tech Transfer
- Risk-based validation: FMEA and CPP/CQA mapping under QbD
- Cleaning validation: Protocols aligned to product and equipment risk
- Tech transfer: Structured packages to ensure reproducibility at partner sites
- Regulatory support: Data packages to support filings and inspections