Best Large Volume Parenterals Factory Setup Consultant
Given their impact on public health, manufacturing pharmaceutical products requires strict regulatory compliance. Among the products manufactured in the pharma industry, parenteral solutions are one of the most critical pharmaceuticals. These solutions are directly administered into the human body by injecting them straight into the bloodstream. Large volume parenterals are large volumes of sterilized injectable aqueous solutions that are packaged in single-dose containers. Owing to their highly sensitive use case, manufacturing parenterals per regulatory quality benchmark is of paramount importance. Moreover, there are regulatory guidelines for large volume parenterals factory setup. We at Pharmadocx Consultants can help you set up a large volume parenterals factory per regulatory standards. Notably, our team has helped set up the highest number of manufacturing facilities in North India. Additionally, we have served more than 600 happy clients.
What are Large Volume Parenterals?
Large volume parenterals or large volume injections are sterile aqueous solutions usually intended for intravenous use. Additionally, they may be administered intraperitoneally or subcutaneously. Their unit dose is at least 100 ml and maybe even be up to 5000 ml. They are typically used to provide fluid replacement therapy to patients. Some common examples of LVPs are solutions containing sodium bicarbonate, electrolytes, dextrose (glucose) and other sugars, amino acids, peptides and other protein-fractions, vitamins, and minerals. Packaged in glass bottles or large volume flexible containers, large volume parenterals are required when large volumes of aqueous solutions have to be administered.
Optimum temperature-controlled manufacturing conditions are required to manufacture parenterals. Additionally, highly-skilled technicians and labour along with specific equipment and machinery are required. Furthermore, compliance with industry quality standards is mandatory to manufacture high-quality, safe, and effective large volume parenterals.
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Large Volume Parenterals Factory Setup: Services We Provide
Detailed project report for large volume parenterals factory setup
We prepare accurate and detailed project reports for setting up large volume parenterals factory. Our report is a comprehensive document that outlines various aspects of a proposed business. It will contain details on how to set up the manufacturing facility and amount of land required. Additionally, we will highlight the type of machinery required for manufacturing the particular drug. Furthermore, we will provide an estimate of the working capital required. Moreover, it will provide detailed insights into the feasibility, scope, and potential outcomes of the business. Basically, our report will serve as a comprehensive roadmap for establishing your business venture.
Land and location selection
Choosing the right spot for starting your large volume parenterals factory is vital. It should have good transport links and no legal issues. Avail the Pharmadocx Consultants land selection service. We will find you the best spot for starting your pharmaceutical manufacturing company.
Factory layout design service
As a pharmaceutical consultant, we will provide support for designing your pharma factory as per regulatory guidelines. We will design the factory as per updated Schedule M, Drugs and Cosmetics Rules, and CE guidelines.
Our service includes designing civil architecture plans, clean room plans of ISO Class 7, HVAC Plans, plumbing plans, electrical plans, and equipment plans. We will visit your premises, take measurements, and design an industry-standard layout as per applicable regulatory guidelines. Our facilities are designed with the aim of efficient working as well as the requisite cleanliness and hygiene levels. Avail our factory layout design service for setting up your large volume parenterals factory in a hassle-free manner.
Drug manufacturing license
We at Pharmadocx Consultants specialize in drug manufacturing license application. Providing regulatory support for the grant of all types of drug manufacturing licenses in India is our forte. From Form 25, Form 28 to Loan license and Test license, our drug manufacturing license service covers it all.
Machine and equipment selection for large volume parenterals factory setup
It is important to choose the right machinery and equipment suitable for your factory. We guide our clients in investing in equipment that ensures quality, maximizes output, and offers long-term reliability. Choosing the right machinery is pivotal for optimal production. Thus, our team will help you select the machines that best align with your factory requirements.
QMS Implementation
As a pharmaceutical consultant, we also help implement Quality Management System (QMS) as per WHO guidelines.
Documentation service
Our team has expertise in regulatory document preparation service as well as preparing documents needed for license application. We offer support in managing and updating essential documentation needed for regulatory compliance. We collaborate with our clients to keep their documentation current and precise, aiding them in achieving their quality and compliance goals. With several years of experience in this field, we will help ensure all your documents adhere to the required regulatory standards.
Schedule M compliance
We provide dedicated Schedule M compliance service. Our team of experts will provide guidance to ensure your pharma factory complies with the new Schedule M guidelines. Additionally, we will revamp your existing factory as per updated guidelines at minimal expenditure with minimum operational disruption. Moreover, we guarantee compliance with all the clauses of the Revised Schedule M.
Certification service for Large Volume Parenterals Manufacturing Plant
Our certification service covers Free Sale Certificate, WHO-GMP, COPP, Market Standing Certificate, GMP, Neutral Code, and Performance Certificate.
Staff training workshops
Our experts will provide comprehensive training to equip your technical staff with the knowledge required to effectively handle regulatory audits. Regulatory guidelines and requirements are constantly being updated. We conduct workshops to educate technical staff with the latest regulatory guidelines.
Why choose Pharmadocx Consultants?
Drugs Licences
Years Experience
Plants Set-up
Our Clients
Why Choose Pharmadocx Consultants for Large Volume Parenterals Factory Setup?
Planning to set up a large volume parenterals factory? We are one of India’s premier pharma consultants. With our large volume parenterals factory setup services, you can easily set up your factory. We follow the best practices for setting up a pharma factory focussing on efficient flow of materials and personnel as well as GMP compliance.
- We have expertise and rich experience in the pharma industry.
- We have extensive knowledge of the pharmaceutical sector and regulatory guidelines. We will leverage our expertise to help you steer through the Indian pharma regulations and easily achieve regulatory compliance.
- By using our documentation service, you can rest assured of having accurate, in-depth, and detailed documents created for license application.
- We understand every client has unique needs and requirements. Hence, we tailor our services to cater to your specific needs.
- We will leverage our expertise to help you select the optimal factory land and machinery suitable for your specific pharma product.
- Our thorough audit service will help your factory not just meet but exceed the stringent Indian drug regulatory standards.
- With our support, you can easily launch or expand your business without unnecessary delays.
Call/Whatsapp us at 9996859227 or write to us at [email protected] to begin a smooth large volume parenterals factory setup journey.
Let's Talk!
We'd love to hear from you! Whether you have questions about our pharmaceutical plant setup consultation services or want to discuss a potential project, our team is here to help. Simply fill out the form below, and we'll get back to you as soon as possible. Alternatively, you can reach out to us directly using the phone number or email address listed on this page. We look forward to connecting with you!
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- Head Office - Opposite Dewan Mill, Old D.C. Road Sonepat - 131001 Haryana, India
- Registered Office - Netaji Subhash Place, Delhi, 110034