Pharma Manufacturing Plant Setup Service refers to a comprehensive solution that assists pharmaceutical companies in establishing compliant and efficient manufacturing facilities.
This service encompasses Facility Design, Regulatory Licenses and Approvals, Good Practices (GxP), and thorough documentation, ensuring seamless production and market readiness.
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Our expertise lies in designing and executing plants in accordance with MHRA and PICS guidelines for various formulations, selecting production machinery, designing environmental requirements, and ensuring compliance with GMP, GLP, and GWP standards.
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Our team specializes in understanding the dynamics of a cosmetic plant design and curating one that adheres to Indian regulatory standards and guarantees compliance with GMP.
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We assist manufacturing companies in setting up a medical device manufacturing plant by ensuring compliance with regulatory standards, developing a clear value proposition, and developing a business plan that includes suppliers, staff, finance, and marketing strategy.
Unlock new market opportunities with a state-of-the-art manufacturing plant. Our consultancy ensures compliance and efficiency. Learn more about our services.
CliniExperts is an apex in providing reliable regulatory solutions, including assisting you in attaining a range of manufacturing licenses. We facilitate obtaining Medical Device Manufacturing License on Form MD-5 and Form MD-9, Drug Manufacturing License on Form-25 and Form-28, Cosmetics Manufacturing License on Form COS-8, Nutraceutical License, and more. Our house of experts, with years of experience and practical efficiency, offers guidance on the application process to ensure successful approval and seamless navigation of the regulatory landscape.
From Licensing, we have come a long way to designing new plants and providing varied services, including HVAC Drawings, Civil Autocad Drawings, Machine GA Drawings, Plumbing Drawings, Electric Drawings, False Ceiling Drawings, and Epoxy Drawings. Our professionals are geared with years of experience and practical knowledge the state-of-the-art software and technologies, guaranteeing accuracy and precision in every aspect of the work. Our designs are carefully curated to minimise waste, enhance efficiency, and ensure effective operations. Reach out to us to learn more about plant design services.
Documentation is the central part and process for regulatory compliance in the medical industry. From obtaining to maintaining various types of documentation—Plant Master Files, Device Master Files, QMS Documents as per ISO-13485 for Medical Devices, WHO-GMP documents, Schedule-M documents, Standard Operating Procedures (SOPs), and Validation Documents—we take great pride in our level of accuracy and efficiency. Our regulatory squad is well-versed with the latest rules and regulations, offering them the upper hand in maintaining and updating the documentation for regulatory requirements. Clear communication and well-charted updates with the clients to ensure proper documentation and compliance objectives are our preferred ways of bringing projects to fruition.
Regulatory submissions require essential certifications like the Letter of Authorization (LOA), Good Manufacturing Practice (GMP), Certificate of Pharmaceutical Product (CPP), and Certificate of Suitability (CEP). We help manufacturers attain necessary certifications, including GMP, GLP, WHO-GMP, EPR From CPCB, ISO-13485, and Free Sale Certificate from CDSCO DCGI FDA, by ensuring end-to-end completion of notarization and legalization to guarantee their authenticity and expedite market access.
Let our experts guide you through the process of setting up a compliant manufacturing plant. Contact us now!
With these certifications, we demonstrate our dedication to quality, safety, and customer satisfaction.
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