Pharmaceutical consulting, with worldwide remote support.
Qualification and validation, GMP compliance, inspection readiness, regulatory services, sterile manufacturing and digital quality from our Pune base, with remote support worldwide where feasible.
Designed around your quality objectives.
Engagements can be scoped as focused reviews, gap assessments, documentation support or lifecycle programmes.
Qualification & Validation
A lifecycle-led approach to facility, utility, equipment and process qualification.
- DQ, IQ, OQ and PQ planning and documentation
- risk-based qualification strategies
- commissioning and qualification readiness
GMP Compliance
Practical support for quality systems, controlled documentation and sustainable GMP execution.
- GMP gap assessments
- SOP and controlled-document review
- document lifecycle support
Inspection Readiness
Make evidence easier to find, explain and defend during customer or regulatory inspections.
- Readiness gap assessments
- evidence-room structure
- document retrieval indexes
Regulatory Services
Connect manufacturing evidence and quality documentation with regulatory expectations.
- Regulatory intelligence and requirement mapping
- CTD/eCTD structure awareness and Module 3 documentation support
- CMC document coordination
Sterile Manufacturing
Support contamination-control thinking across sterile facilities, processes and critical utilities.
- Contamination Control Strategy (CCS) support
- EU GMP Annex 1 readiness
- cleanroom and HVAC qualification
Digital Quality & CSV
Build a risk-based foundation for compliant digital systems and automation.
- Computerized system inventory and GxP impact assessment
- validation planning
- user requirements and traceability
Headquartered in Pune.
Remote services available worldwide.
With our headquarters in Pune, Maharashtra, India, we offer remote technical collaboration to pharmaceutical manufacturers and consulting teams worldwide. Each engagement is assessed against its technical scope, applicable requirements, available evidence and delivery needs.
International remote collaboration
Remote document review, qualification planning, gap assessments, regulatory CMC coordination and training can be scoped for clients worldwide. International projects are planned around the target market, applicable requirements, working language, time-zone coordination and secure document exchange.
Work that needs site attendance
Physical inspections, witnessing and execution activities may need an on-site arrangement. Location, specialist availability, access requirements, travel and commercial terms are confirmed in the proposal before any site work is committed.
Projects involving more than one facility
Tell us which locations and systems are involved and where documentation or processes differ. A common planning framework can be proposed, with site-specific evidence and approval responsibilities defined for each facility.
Discuss your facility and project scopeDefined scope.
Usable outcomes.
Each engagement begins by clarifying the objective, applicable standards, current state, available evidence, stakeholders and expected deliverables. We then agree the scope, review approach, assumptions, responsibilities and timelines.
Outputs may include gap registers, review comments, action trackers, requirements matrices, document structures, training material or draft documentation for client review. Final approval and regulated decisions remain with the client's authorised personnel.
Request a scoping discussion →