We help organizations implement, maintain, and strengthen GMP and GLP systems across all functions. Our services include: cGMP & cGLP Implementation: Establish robust quality systems aligned with global regulatory expectations. Gap Analysis & Compliance Audits: Identify weaknesses, evaluate processes, and recommend corrective actions. CAPA Management & Inspection Readiness: Prepare your team and facility for USFDA, MHRA, WHO-GMP, and ISO inspections, ensuring confidence and compliance. Value: Minimize regulatory risks, avoid non-compliance penalties, and build trust with regulators and customers.

Technology Transfer Support: Ensure smooth transition of processes from R&D to production while maintaining regulatory standards. Responses to Regulatory Queries: Expert guidance to address inspections, audits, and queries efficiently. SOP & Policy Development: Draft and implement SOPs that meet regulatory and operational requirements. Value: Accelerate approvals, reduce delays, and ensure your operations meet global standards.

Our services strengthen your QC lab operations and analytical capabilities: Analytical Method Validation: Ensure methods are accurate, reliable, and compliant with ICH guidelines. Stability Studies (ICH Q1): Plan and execute stability studies for regulatory approval and product shelf-life assurance. Instrument Qualification & Calibration: Ensure laboratory instruments perform accurately and consistently. Specification Harmonization: Align product specifications with regulatory and industry requirements. Value: Guarantee product quality, consistency, and regulatory compliance while reducing batch failures.

People are at the heart of a quality culture. We provide: GMP, GLP & ISO Customized Training: Tailored programs for staff at all levels, from operators to managers. Skill Enhancement Workshops: Build competence in audits, documentation, and analytical processes. Audit Preparedness Programs: Train teams to confidently handle internal and external inspections. Value: Empower your workforce, reduce human errors, and strengthen organizational compliance culture.

We offer complete end-to-end project solutions for pharma and healthcare facilities: Facility Design & Layout Planning: Optimized design for production efficiency and regulatory compliance. Utilities & Cleanroom Solutions: Complete HVAC, water, and cleanroom systems for sterile and non-sterile operations. End-to-End Project Execution: From concept to commissioning, ensuring timely and cost-effective delivery. Validation & Regulatory Approval Support: Comprehensive qualification, validation, and documentation for inspections. Value: Reduce project risk, avoid delays, and launch compliant facilities ready for production and regulatory approval.

Beyond compliance, we help organizations build long-term operational excellence: Process Optimization & Risk Assessment: Improve efficiency, reduce waste, and mitigate operational risks. Quality Culture Transformation: Embed quality as a core value in every process and team. Strategic Guidance for Startups & SMEs: Tailored support for new pharma ventures, ensuring regulatory readiness and sustainable growth. Value: Transform your operations into efficient, compliant, and future-ready organizations.

Navigating the pharmaceutical supply landscape can be complex, with critical decisions impacting compliance, quality, and cost-efficiency. At PharmaHealth Insights, we provide end-to-end procurement guidance to help you select the right vendors and equipment for your facility: Pharma Equipment & Machinery: Guidance on selecting production machines (tableting, filling, coating, ointment manufacturing) that are compliant, reliable, and scalable. Quality Control Instruments: Advice on analytical instruments, lab equipment, and automated systems that meet regulatory standards and operational needs. Water & Laboratory Systems: Support in choosing WFI, purified water systems, and laboratory-grade water systems that maintain compliance and ensure product safety. Primary Packaging Materials & Raw Materials: Recommendations on trusted suppliers for tubes, bottles, closures, vials, powders, liquids, and excipients to ensure consistency and regulatory compliance. Stability Chambers & Environmental Equipment: Guidance on procuring temperature and humidity-controlled chambers that support ICH-compliant stability studies. Vendor Evaluation & Qualification: Assistance in evaluating potential suppliers, negotiating terms, and qualifying vendors to meet GMP and quality requirements. Value: Reduce procurement risk, avoid compliance pitfalls, and ensure long-term reliability by partnering with trusted vendors who deliver quality, regulatory compliance, and cost-efficiency.

Maintaining optimal environmental conditions is critical in pharmaceutical manufacturing, especially for sterile and non-sterile production areas, laboratories, and storage spaces. At PharmaHealth Insights, we provide end-to-end HVAC system calibration and validation services to ensure your facility meets GMP compliance and operational efficiency: Design Qualification (DQ) Support: Review and advise on HVAC system design to ensure compliance with GMP, ISO, and WHO standards. Installation Qualification (IQ) Verification: Ensure that all HVAC components are installed correctly, following design specifications. Operational Qualification (OQ) Testing: Evaluate system performance under operating conditions, including airflow, temperature, humidity, and pressure differentials. Performance Qualification (PQ) Validation: Confirm that HVAC systems consistently maintain required cleanroom classifications and environmental conditions during routine operations. Calibration of Critical Instruments: Regular calibration of temperature sensors, humidity controllers, pressure gauges, and particle counters to maintain accuracy and compliance. Routine Monitoring & Requalification: Establish schedules for preventive maintenance, periodic requalification, and environmental monitoring to ensure long-term compliance and efficiency. Value: Protect product quality, ensure personnel safety, maintain regulatory compliance, and extend the life of critical HVAC systems.

At PharmaHealth Insights, we take pride in our state-of-the-art manufacturing facility located in Bengaluru, spanning 22,500 sq. ft., dedicated to delivering high-quality HVAC systems, cleanroom solutions, and laboratory infrastructure for pharmaceutical, biotech, and healthcare industries. Our in-house capabilities include: HVAC Systems & Air Handling Units (AHUs): Design, fabrication, and installation of compliant, energy-efficient, and precision-controlled HVAC and AHU systems for sterile and non-sterile production areas. Laboratory Furniture: Custom-built modular lab benches, storage solutions, and workstations, designed to meet ergonomic and GMP standards. Cleanroom Panels & Doors: Manufacturing modular walls, ceilings, and doors for various cleanroom classifications (ISO 5–8) with durability, precision, and contamination control. Dampers & Grills: Fabrication and supply of high-precision air dampers, supply/exhaust grills, and diffusers to optimize airflow and maintain cleanroom integrity. Pass Boxes & Material Transfer Systems: Production of manual and automatic pass boxes, interlocking systems, and material transfer units for contamination-free operations. Laminar Airflow (LAF) Units & Biosafety Cabinets: High-quality vertical and horizontal LAF units, Class II biosafety cabinets, and other controlled airflow solutions for microbiology and sterile handling applications. Why it matters: Having a fully equipped in-house facility allows us to maintain stringent quality control, customize solutions as per client requirements, reduce lead times, and provide end-to-end support — from design and fabrication to installation, validation, and after-sales service. Our Bengaluru facility combines advanced machinery, skilled engineers, and a quality-driven approach to ensure every component meets global standards and supports your compliance and operational excellence goals.