Establishment and regulatory support for Ready-to-Use (RTU) Cartridges, Vials, Ampoules, and Prefilled Syringes (PFS) manufacturing facilities, including cleanroom design, equipment qualification, process validation, and inspection readiness.
Biosimilar Manufacturing Plant Establishment
Comprehensive consultancy for biosimilar manufacturing facilities, including facility planning, process development, technology transfer, quality systems, validation, and global regulatory compliance.
Vaccine & Biopharmaceutical Projects
Specialized consultancy for vaccine manufacturing, plasma-derived products, biologics, biosimilar, and biotechnology facilities.
Sterile Manufacturing Facilities
Planning, design review, qualification, and regulatory support for sterile injectable manufacturing plants.
Technology Transfer Projects
Support for product transfer between manufacturing sites while maintaining quality, regulatory compliance, and process consistency.
Validation Projects
Execution and documentation of DQ, IQ, OQ, PQ, Process Validation, Cleaning Validation, CSV, and Equipment Qualification.
Regulatory Compliance Projects
Implementation of regulatory requirements to achieve inspection readiness for agencies such as US FDA, EU GMP, MHRA, WHO GMP, PIC/S, and CDSCO etc.
