Successful pharmaceutical projects require seamless coordination between engineering, quality assurance, regulatory compliance and validation teams. We provide end-to-end project management support from concept development and facility design through commissioning, qualification, validation and inspection readiness. Our project management approach is aligned with revised Schedule M, WHO Technical Report Series, EU GMP Guidelines, PIC/S GMP Guide and applicable international engineering best practices.
What We Deliver
- GMP Compliance Review — Independent review of facility design against WHO-GMP, revised Schedule M, EU-GMP and PIC/S requirements.
- Utility System Review — Review and planning of purified water, WFI, clean steam, compressed air, nitrogen and other critical utilities.
- Equipment Selection & URS — Preparation and review of User Requirement Specifications (URS) and technical evaluation of manufacturing equipment.
- Material & Personnel Flow Assessment — Design of optimized movement pathways to minimize contamination risks and ensure regulatory compliance.
- Commissioning Oversight — Technical support during installation, commissioning and system acceptance.
- Vendor Qualification Support — Evaluation and technical review of equipment and utility suppliers.
Our Approach
Project Planning
Understand manufacturing requirements, dosage forms, regulatory expectations and project objectives.
Facility Design & Engineering
Develop GMP-compliant layouts, utility concepts, engineering specifications and workflow optimization.
Execution & Qualification
Coordinate installation, commissioning, qualification and validation activities.
Inspection Readiness & Handover
Support regulatory inspections, resolve observations and facilitate successful commercial operations.
Who this is for
Why Choose Vaayath
- 20+ years of pharmaceutical regulatory experience
- Expertise in WHO-GMP, EU-GMP and revised Schedule M
- Experience with greenfield and brownfield projects
- Independent engineering and GMP reviews
- Qualification and validation specialists
- End-to-end project lifecycle support