Our Greenfield/Brownfield Project Services
A Master Plan also called a comprehensive plan, provides a long- term vision for the built environment of Pharmaceutical Factories and Laboratories. It guides the appropriate use of lands in order to plan and envisage future growth potential. As a result, the Master Plan has a direct relationship with the growth of the organization.
Project management in our field of operations consists of the application of knowledge, abilities, tools and techniques which enables us to complete project activities in order to satisfy customer requirements and thus accomplish the final goal with efficacy and efficiency.
Concept Engineering will be a crucial document to decide the project plan and will be a base document for Detailed Engineering. This involves the initial conceptualization of the entire project which helps in forming the foundation on which the rest of the project is built up.
Regulatory Compliance Support
I. ADVISORY SERVICES
cGMP (Current Good Manufacturing Practice) Compliance
Advisory services to queries pertaining to Pharma GMP, GLP, QA and Regulatory Affairs
Compliance audits as per current and updated statutory pharma regulations
Technical Due diligence for Mergers & Acquisitions
II. TECHNICAL ASSISTANCE
Site Master Ule as per PIC/s & Local FDA requirement
Quantitative Risk and Assessment (QRA)
Environment Impact Assessment (EIA)
Safety Audits Energy Audits
Process Engineering including selection of the right equipment
Building Management and Automation Systems
Preparation of Detailed SpeciUcations, Data Sheets and Bill of Quantities for various Plants, Equipment, Machinery and System
Supply of various Plant Equipment, Machinery and Systems
Our team of multi-functional life science consultants have proven success in managing product and process transfers for our clients.
Our team will demonstrate how to transfer your product or process in the most eFcient manner possible, ensuring compliance along the entire way.