PGA CONSULTANT

• Pharmaceutical formulation
• Bulk drug manufacturing
• R & D
• Nutraceuticals

 Plant setup and design
We provide expert plant setup and design services adhering to international standards such as WHO, US FDA, EU GMP and other regulatory requirements. Whether it's a new facility or an expansion, our designs ensure compliance, efficiency and sustainability. 

Project Management Services
Our comprehensive project management solutions cover greenfield, brownfield and turnkey projects. From initial concept to final handover, we offer end-to-end assistance to ensure your project is completed on time within budget and to the highest quality standards. 

 Engineering Support
We offer a full range of engineering support services including design assistance for facilities, utilities, clean room panels, AHU systems and equipment. Our team ensures that all aspects of your infrastructure are optimized for performance, safety and compliance.  

  Audits and Compliance Solutions
We conduct thorough audits to assess your facility's compliance with relevant regulatory standards. Our team identifies potential gaps and provides actionable solutions to ensure your plant meets all necessary regulations, minimizing risk and improving performance. 

   Qualification Services
We provide qualification and validation services for all necessary activities, ensuring your facility meets industry-specific regulations and operational excellence. Our team handles everything from equipment qualification to process validation and facility commissioning. 

    Documentation Support for Quality Management System (QMS)
We provide comprehensive documentation support for your Quality Management System (QMS), ensuring that all processes, procedures and records meet regulatory standards. Our expert team helps create and maintain robust documentation to enhance your facility’s compliance and operational efficiency. 

   Tailored Training for Operational Excellence
We offer customized training programs designed to boost your team’s operational capabilities and ensure continuous improvement. Our training covers key areas such as quality assurance, regulatory compliance, process efficiency and best practices to achieve operational excellence. 

    Audit and Certification Preparation
We ensure your plant is fully prepared for audits and certifications by helping you navigate the entire process with ease. Our expert team will guide you through the necessary steps to secure the required certifications while maintaining compliance with industry standards. 

    Expert Regulatory Services
Our regulatory services provide you with the expertise needed to navigate complex regulations. From ensuring compliance with global standards to managing submissions and approvals, we support you in meeting regulatory requirements and achieving certification.  

     R&D and Technology Transfer Services
We provide specialized R&D and technology transfer services to help you innovate and scale efficiently. Our team supports the seamless transfer of technology from development to commercial production, ensuring the optimization of processes, equipment and systems. We collaborate closely with your team to ensure that all technical aspects are thoroughly understood and successfully integrated, facilitating smooth transitions and accelerating time-to-market.  

  Software Solutions for Pharma
We offer innovative software solutions tailored specifically for the pharmaceutical industry. Our software is designed to optimize manufacturing processes, streamline compliance and enhance operational efficiency. From batch management to quality control, our solutions ensure your operations run smoothly while adhering to global regulatory standards.

• Guidance regulatory compliance 
• GMP set up
• Facility set up
• QMS set up
• Qualification activities
• Validation activities
• Process simplification
• Productivity improvements
• Quality culture transformation

• QMS audit- Quality system audit
• Gap audit-Auditing facility for gap and providing compliance strategy for all regulatory bodies
• Vendor audit
• Mock Audit-Audit prior to regulatory audit
• Third party manufacturing site audit
• Internal audit
• Customized audit as per client need

•  Quality Management System (QMS)
• Document Management System
• Learning management system
• Batch Record Management System
• Laboratory Information Management System
• Calibration Management System
• Breakdown Management System
• Preventive Maintenance Program
• Annual Product Quality Review