Project Services
New Pharma Plant Setup
Facility planning support, layout coordination, project planning, vendor coordination and implementation tracking.
Technical Capabilities
Our Services
Explore pharma plant setup, infrastructure, engineering, third party manufacturing, equipment, instruments, validation, calibration and documentation support services.
Infrastructure
PUF / PIR Panel & Cleanroom
Cleanroom wall and ceiling panel coordination, partitions, coving, flush finishes, sealing and controlled-area fit-out.
Infrastructure
Pharma Doors & Accessories
Cleanroom doors, flush doors, vision panels, interlocking coordination, door hardware and installation support.
Engineering
HVAC, AHU & Air Handling
HVAC system planning and coordination, AHU, ducting, HEPA filtration, air balancing and qualification support.
Equipment
Pharmaceutical Manufacturing Equipment
Equipment requirement assessment and sourcing/installation coordination for production and packaging areas.
Instruments
QC & Microbiology Instruments
Instrument requirement assessment and coordination for analytical, QC and microbiology laboratories.
Quality & Validation
Validation, Qualification & Calibration
IQ/OQ/PQ documentation support, instrument calibration coordination, HVAC validation, thermal mapping and equipment mapping.
Documentation
Pharma Dossier & Technical Documentation
Product dossier compilation support, technical document organization and CTD/eCTD-related document coordination where applicable.
Engineering
Utilities & Production Area Support
Project coordination for production areas and associated utility requirements, based on approved engineering design.
Manufacturing Solutions
Third Party Manufacturing
Support to identify and coordinate with suitable licensed contract manufacturers, review product requirements and facilitate quotation and documentation communication.
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Project Services
Project Management & Vendor Coordination
Scope tracking, technical communication, quotation comparison support and coordination across project stakeholders.
Quality & Validation
Compressed Air & Utility Validation
Sampling/validation coordination and reporting support for agreed utility points and test scope.
Compliance
GMP & Revised Schedule M Documentation
Gap assessment and documentation preparation support; applicability and final requirements to be confirmed for each site.
Founder-led professional support
Pharmaceutical & Nutraceutical Consultancy
Professional support based on the individual industry experience and specialist team coordination described by SIKANDAR KUMAR.
Greenfield Project Advice
Initial guidance for new pharmaceutical and nutraceutical projects, plant planning, project scope and operational requirements.
Plant Inspection, Audits & Gap Assessment
Plant inspection support, internal and external audit preparation, third-party audit coordination, audit observations and compliance follow-up.
Pharma Documentation
BMR, BPR, SOPs, protocols, formats and supporting GMP documentation, including WHO-GMP and EU-GMP related document support as applicable.
Analytical Method Validation
AMV (Analytical Method Validation) and verification documentation and coordination support.
Qualification & Validation
AHU qualification and DQ, IQ, OQ and PQ documentation, protocols, formats and supporting validation records for applicable plant systems.
Sample Analysis & Reports
Coordination for product sample analysis and reports through suitable laboratories/service providers, subject to agreed scope and authorization.
Materials & Procurement Support
Enquiry and procurement coordination for columns, chemicals, pharmaceutical machinery and plant-related requirements.
Technical Discussion & Documentation
Discussion and documentation support for pharmaceutical and nutraceutical plant operations, compliance and technical requirements.
Dosage Form & Department Exposure
Tablets, capsules, oral liquids, sterile injections, ointments, beta-lactam, cephalosporin dry syrup, sex-hormone products, nasal sprays, herbal and nutraceutical departments.
Audit and regulatory experience areas stated: USFDA, TGA, MHRA, MCC and EU-related audit environments, including internal, external and third-party audits. This describes professional exposure/support areas only; it does not imply that SHAN is an approved auditor, regulator, certified organization or that any audit outcome is guaranteed.
Service availability, execution responsibility, equipment brands, technical specifications, testing scope and deliverables are confirmed in a written quotation or project agreement. Regulatory approvals and certifications are issued only by the competent authorities or authorized bodies; SHAN does not imply guaranteed approval.