Consultancy Services
Hands-on pharmaceutical & medical device consulting — from troubleshooting methods to achieving ISO accreditations with sustainable operational excellence.
Practical, Compliant, and Scalable Consulting
We support manufacturing and R&D teams with shop-floor interventions, documentation, audits, training, and accreditation readiness.
Our Core Consultancy Capabilities
Method Troubleshooting & Lifecycle
Analytical method & technique troubleshooting with risk-based lifecycle management.
New Lab Setup & Qualifications
End-to-end support for manufacturing and R&D labs — layout, URS, IQ/OQ/PQ, and readiness.
Shop-floor Investigations
On-site laboratory investigations and CAPA alignment at the lab shop floor.
QC Operational Excellence
Lean QC workflows, right-first-time metrics, and cost reduction initiatives.
Technical Report Writing
Protocols, reports, SOPs, and regulatory response documentation.
Inspection Handling
Customer and regulatory inspections — readiness, mock audits, and front-room/back-room support.
Complaint & Deficiency Handling
Structured RCA, remediation plans, and regulatory deficiency closures.
Technical Trainings
Skill development workshops for analysts, reviewers, and QA — customized curricula.
Accreditation Readiness
Support for ISO/IEC 17025 and ISO/IEC 17034 — gap assessment to successful assessments.
Why Engage Dr Sahu’s Consultants
- Hands-on chemists with multi-instrument expertise (HPLC, GC/GC-MS, LC-MS/MS, ICP-MS).
- GLP mindset, data integrity by design, and documentation rigor.
- Rapid turnaround on investigations and interim controls.
- Cost-to-quality balance using lean principles and digital traceability.
- Proven playbooks for inspections and accreditation journeys.
How We Engage
On-site Interventions
Focused shop-floor days for critical issues (OOS/OOT, investigations, audit prep).
Project-based
Defined scope with deliverables — e.g., lab setup & qualifications or 17025 readiness.
Retainer Advisory
Ongoing mentoring, document reviews, and inspection support with SLAs.
Typical Delivery Steps
Request a Consultation
Tell us your challenge — we’ll propose a practical, compliant, and cost-effective plan.
