Validation Services
Commissioning and Qualification
Facilities and equipment are commissioned and qualified in accordance with regulatory standards (USFDA, EU, WHO, PICS, and ISPE C&Q Guidance Volume V, 2019).
Computer Systems Validations
Ensure compliance with 21 CFR Part 11, EU Annex 11, USP<1058>, and ISPE GAMP 5, safeguarding data integrity and operational reliability.
- Strategy development & growth
- Market research & competitors
- Risk management
Process Design, Facility Design & Project Management
Process & Facility Design
Innovative planning and design solutions tailored to optimize manufacturing operations.
Project Management
Comprehensive services covering:
- Project Charter & Scope Mapping: Outlining objectives and project boundaries.
- WBS and Project Scheduling: Creating a clear roadmap with defined milestones.
- Resource Planning: Optimizing manpower and material resources.
- Critical Path Identification and Tracking: Ensuring timely project delivery by monitoring key tasks.
- Budget Tracking: Maintaining financial oversight throughout the project.
- Project Reports and Close Out: Delivering detailed progress reports and efficient project completion.
Automation – SCADA, PLC, DCS, MES
MES Capabilities
End-to-end MES project solutions including planning, implementation, testing, and deployment.
DCS Capabilities
Designing, implementing, testing, and commissioning DCS projects to enhance process control and automation.
Consulting & Documentation
Consulting Services
Strategic consultation on pharma, biotech, food, and cosmetics manufacturing—from conceptual design to final release.
Expertise in regulatory compliance covering bodies such as WHO, FDA, MHRA, TGA, EU, HTM, and ISO.
Documentation Services
Developing tailored documentation to meet industry standards and compliance requirements.
Risk Assessments & Contamination Control Strategy
Conducting detailed evaluations to mitigate risks and maintain high quality.
Regulatory Affairs
Dossier Preparation & NDA Submission
Assisting with comprehensive dossier preparation and streamlining New Drug Application (NDA) submissions.
Compilation and Review of CMC
Coordinating Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory excellence.
Preparation of Common Technical Documents (CTD)
Managing modules 1 to 5 to ensure regulatory submissions are complete and compliant.
Regulatory Strategy and Clinical Development Planning
Offering strategic planning to navigate the clinical development and regulatory landscape.
Trainings
Current Good Manufacturing Practices (cGMP)
- Concepts and Implementation: Fundamental cGMP principles with practical application.
- Specialized Training: Tailored courses for drug manufacturers and active pharmaceutical ingredient (API) producers.
- Workshops: Annual sessions covering Data Integrity, Audits, Quality, Validation, and Compliance.
Validations and Qualifications Training
Comprehensive courses on facility, equipment, process, and analytical method validations, including Computer Systems Validation, Quality Management, Quality Risk Management, and Laboratory Controls.
Engineering Training
- Facility Design: Principles and practices for efficient design.
- Cleanrooms and HVAC Systems: Standards for maintaining controlled environments.
- Bio-process Unit Operations: Focused training on cell culture, microbial fermentation, chromatography, and tangential flow filtration (TFF).
- Process Equipment: Detailed insights into operational equipment needs.
This detailed breakdown emphasizes the breadth and depth of VSGPL’s expertise, making it easy for potential clients to understand the comprehensive service offerings.
Transparent. Collaborative. Results-Driven.
At our company, every project begins with a deep understanding of your unique needs. We believe that a successful partnership is built on transparent communication, collaborative innovation, and a methodical approach that transforms challenges into measurable results.
Discovery & Strategy
Planning
Execution & Implementation
Monitoring & Optimization
Driving Growth Through Strategic Clarity
Celebrating Excellence
We’re proud to be recognized for our innovation and impact. Our awards reflect our commitment to quality, excellence, and the trust our clients place in us.
Why Our Clients Love to Work with Us!
