Plant Setup & Upgradation
Building Tomorrow’s Pharmaceutical Facilities Today with our Setup and Upgradation Services
We handle fully assembled pharmaceutical and biotech projects, understanding that pharmaceutical plant design is a crucial field and poor design can lead to significant errors. We utilize our expertise in pharmaceutical production plant design, regional building resources, architectural restrictions, and regulatory requirements. Our ability to develop GMP-compliant production facilities for clients ensures successful foreign audits and ensures the success of pharmaceutical production plants.
The conception stage is crucial for establishing an effective plant setup, which involves setting objectives, conducting feasibility studies, selecting the ideal location, creating basic designs, managing finances, adhering to regulations, and assessing potential risks to ensure immediate production objectives and industry requirements are met.
We assess and choose optimal sites, create detailed engineering and architectural plans, ensuring safety, scalability, and strategic placement of equipment for future expansions and technology updates, while adhering to all rules.
To ensure the success of the pharmaceutical facility, we offer complete field details, including construction specifications, equipment layouts, utility systems, effective workflow, and safety features, as well as geological, topographical, geotechnical, and hydrological advice from the field experts for solid groundwork.
Our expert procurement support ensures that your plant setup is equipped with high-quality resources, delivered on time, and within budget, paving the way for efficient and compliant operations. We assist in researching and selecting reliable suppliers, evaluating equipment needs, bidding processes, and securing best deals.
We offer comprehensive installation and validation services for manufacturing equipment, ensuring compliance with GMP standards. Our services include Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to verify proper setup, functional performance, and reliable operation.
The equipment, utilities, and facilities must be GMP compliant, and validation is conducted to ensure reproducibility in production, cleaning, analytic methods, and computer systems.The process involves systematic testing and verification of all systems and equipment to ensure their correct installation and functionality.We guarantee equipment and systems are installed to specifications and confirm system operation under various conditions, ensuring consistent real-world results.
We handle all validation project requirements, including URS, FRS, DQ, SAT, FAT, commissioning documents, IQ, PQ, OQ, PV, and validation report writing.
Our services cover vendor identification, contract management, performance monitoring, and regulatory compliance, ensuring high-quality, cost-effective and timely supply chain operations.
We provides entire computer system development and validation services, including design, installation, operational, and performance qualification, ensuring robust, reliable, and industry-compliant systems.
If your API or formulation plant has already secured approval from the local regulatory body and youaim to enter regulated markets like the USFDA, EMEA, WHO, MHRA, PIC/S, etc., you mayconsider utilizing our Plant Upgradation Service.
We offer a entire assessment of your facility’s current state, identifying areas of enhancement to meet the stringent criteria of regulatory targets, ensuring a precise scope for targeting specific authorities such as the USFDA, EMEA, WHO, MHRA, and PIC/S
A GAP audit is a crucial step in ensuring compliance with regulatory standards and optimizing operational efficiency in API/Formulation plants. Our process involves a thorough evaluation of current practices and facilities, and provides a report on identifies areas of non-compliance and suggests necessary actions to ensure your facility meets regulatory standards and operates at optimal performance.
Our CAPA plan preparation service involves a thorough analysis of audit findings, the development of corrective and preventive actions, and the establishment of an implementation strategy with monitoring mechanism for continuous improvement.
We meticulously identify gaps through stringent assessment and then create a time-bound milestones for the upgradation process.
This structured approach ensures systematic progress toward aligning your operations with regulatory standards and achieving optimal efficiency with defined timelines.
Our team evaluates current plant layouts, identifies areas for improvement, and implements strategic changes to optimize workflow efficiency, enhance safety measures, and ensure regulatory compliance, ensuring optimal operational needs and regulatory compliance.
Our specialized service involves reviewing existing SOPs, identifying gaps, and developing updated protocols for specific operations. This ensures compliance with evolving regulatory standards and industry best practices, enhances operational efficiency, mitigates risks, and upholds the highest quality and safety standards.
Our approach to policy redesign involves a thorough review of existing policies, identification of areas for improvement, and the development of updated ones that reflect best practices and address emerging challenges. This helps organizations strengthen governance, enhance compliance, and foster a culture of continuous improvement.
Our comprehensive programs cover topics like GMP and GCP guidelines, SOPs, regulatory updates, and safety protocols. We customize training modules to meet your organization’s needs, delivering engaging sessions through workshops, webinars, and interactive sessions. Investing in training empowers your team with the necessary knowledge and skills to excel and contribute to your organization’s success.
We specialize in creating or restructuring customized QMS for your organization, ensuring regulatory compliance and operational excellence through needs assessment, system design, implementation, staff training, and continuous monitoring.
We specialize in creating customized Internal Audit Systems for your organization, ensuring complete coverage, regulatory compliance, and continuous improvement, thereby strengthening governance and risk management practices.
We work on task immediately and complete it within timelines
Our experts team are well qualified with the field experts and with years of experience
With years of experience, we are updated with all relevant policies and SOPs.
Our team support you in every aspect of your process, and ensure you to assist in any loopholes
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