Optimizing Quality Via Strategy

GMP / GLP / GCP / FDA / ISO | QMS Transformation | Contract Manufacturing & Commercialization

01

QMS Transformation

End-to-end design and implementation of ISO/FDA-ready Quality Systems.

03

Commercialization

Lifecycle management and market entry strategy for complex therapeutics.

02

Regulatory Auditing

Gap analysis and pre-inspection audits for GMP, GLP, and GCP readiness.

04

Remediation

Expert response to FDA 483s, Warning Letters, and Consent Decrees.

Industry

Focus

Primary Frameworks

Pharmaceutical

Small Molecule & Biologics

cGMP, 21 CFR 210/211

Biotechnology

Advanced Therapy Medicinal Products

GTP, GVP, ISO 13485

Consumer/OTC

Home Care & Personal Care

ISO 22716, 21 CFR 110/111

Principal & Head of Practice

Operational Quality Leader with 20+ years in Life Sciences.

Focused on aligning strategy with strict compliance, our principal leads QMS transformations and regulatory audits that secure market access and operational resilience for global clients.

RAC-Drugs

ISO Lead Auditor