Project Management

API First with a team of experts manages both green field and brown field projects. We offer support and guidance for complete projects or also for individual steps. Our team is specialized in preparation of plant layouts related to OSD formulations, bulk drugs, parenteral etc. The layouts are designed as per current applicable GMP norms of USFDA, EU, MHRA, TGA, PIC/s, WHO, Schedule M etc. We also support our clients in planning, organization, partner selection, coordination, monitoring, and controlling of development processes.

API First has a team of experts having in-depth knowledge and understanding of the global pharmaceutical requirements for production and marketing of various formulations.

We prepare plant layouts, man material layouts, AHU zoning layout, Differential pressure layout etc. We also support our clients in preparing URS, conducting FAT/SAT, equipment selection and vendor identification. We also provide support for identification and terms finalization with the vendors of AHU, Water System, utilities etc.

Key features:

Man and Material Movement
Process & Utility equipment sizing & selection
Process flow diagrams and P & I Diagrams
Equipment specifications
Process control Philosophy & Process control logic
Conducting FAT/SAT
Carrying out DQ, IQ, OQ and PQ of equipment
Guidance through the entire commissioning stage

API First is a team of regulatory experts who are well versed with the nuances of the regulatory filing and subsequent approval processes of drugs in India as well as other regulatory countries. The team of experts have a vast experience with the drug approval process in India.