GMP & Inspection Readiness
Mock inspections run to the format and pace of the real thing — CDSCO, State FDA, WHO-GMP and importing-country authorities — with findings classified by risk.
Pharmaceutical quality & compliance consultancy
Build a plant that is ready on the day the inspector arrives.
Twenty years inside pharmaceutical manufacturing — quality assurance, production and projects — applied to GMP compliance, Revised Schedule M readiness, validation and quality systems.
- 20+
- Years in the pharmaceutical industry
- 15+
- Regulatory agencies faced in audits
- 12+
- Dosage forms & container systems
Capabilities
Six areas where we do the deepest work
Revised Schedule M Transition
Clause-by-clause gap analysis, a remediation roadmap sequenced by risk, and the evidence dossier to present the transition to your inspector.
Validation & Qualification
Process and cleaning validation, equipment, facility and utility qualification — protocols with a rationale that survives close review.
Quality Management Systems
Deviation and CAPA that closes, change control that holds, and an APQR that actually tells you something.
Sterile & Lyophilised Products
Contamination control strategy, media fill design and worst-case rationale, environmental monitoring and cycle validation.
International Market Access
Site Master Files, registration dossiers and inspection support across Africa, South-East Asia, Latin America and the CIS.
The client platform
Your engagement, without the email archaeology
Book and track engagements
Request a site visit, an audit or a review, and follow it from enquiry through to closure without chasing email threads.
Everything in one place
Protocols, gap assessments, CAPA responses and reports held against the engagement they belong to.
Separated by design
Each client organisation sees only its own data, enforced in the database itself rather than by the interface.