We provide total solution for setting up a pharmaceutical factory, from concept to commissioning. It’s a one roof solution where we will take care of all the work required for such project, from factory designing, architecture & structural designing, HVAC designing, electrical designing, water system designing, equipment & machinery sourcing, etc.
PLUS we offer technology transfer, which is the most important part of the project.
We also offer after commissioning service for technical assistance and working of the factory on a daily basis.
Our group is dedicated to providing and sharing our knowledge with the pharmaceutical industry globally, so our Company ventured into this segment. We are associated with best companies and professionals in this field of providing high end, and knowledge-based, end-to-end solution provider to the pharmaceutical industry.
OUR TEAMS ROLE :
- Market Research & Product Selection
- Techno-Commercial Feasibility study for – New Manufacturing
- Pre-feasibility & Feasibility studies
Facility – Extension or Modification of an existing plant.
- Business Plan
- Site Selection Studies
- Benchmarking
Conceptual Design& Basis of Design Development :
- Site Master Planning
- Conceptual Design Development
- GMP Risk Assessment
- EHS Risk Assessment
- Containment Strategies
- General Planning & Engineering
- Technology Selection
- Equipment Study & Procurement
- Civil & Architecture
- Expansion/Relocation/ Integration Planning
Engineering :
- Detailed Building Engineering including:
- Architectural
- Civil
- Structural
- Process
- HVAC
- Electrical
- Mechanical & Piping
- Utilities
- Plumbing
- Instrumentation & Automation
- Fire & Safety
- Environmental
Construction Management :
- Inter – Disciplinary Construction and Project Management
- Construction Supervision
- Time Cost Estimation
- Bill Certification
Procurement Assistance :
- Preparation of Detailed Vendor List
- Floating of Equipment Enquiry / Tender Documents
- Follow up for offers.
- Techno-commercial evaluation of offers / bids
- Approval of GA drawings
Documentation :
• Validation Master Plan • GMP Risk Analysis • Qualification Protocols for Process Equipments, PLC, HMI, SCADA, Camera System • Computer System Validation • Quality Management Systems • SOP’s for Production, Warehouse, QC, Cleaning, etc. • Support Services for Process Validation • Supervision for onsite Validation & Compile Reports
Our projects are designed as per WHO GMP USFDA, EU GMP, ANVISA, PICS, TGA Australia Guideline and USFDA CFR 210 & 211.
Manufacturing operations and activities, including but not limited to:
•Formulation
•Fill and finish
•Chemical synthesis
•Cell culture and fermentation, including for biological products
•Analytical testing and other laboratory services
•Packaging and labeling
•Sterilization or terminal sterilization
Segments :
– Orals (tablets and capsules).
– Injectable. (powder and liquid).
– Lyophilized.
– Cream and ointments.
– Syrups.