The evolving space of Indian manufacturing has widened the scope of consulting in various industrial domains. Process management and compliance to global standards are areas of concern for which enterprises rely heavily on their consultant partner for key insights. Companies in pharmaceutical, cosmetics, medical devices, food manufacturing or primary packaging have to adhere to strict compliance with product quality standards and regulatory requirement. This has created the need for niche consulting services. The companies in these industries often face the greatest difficulty in complying with regulatory requirement and standards. They are looking for service providers who could fulfil the requirement of standards and regulatory needs for their product and product packaging.
Hence, there is an increasing demand for consultancy services to develop the right infrastructure for regulatory compliance and standards. A comprehensive overview on varying industry standards as product and packaging accepts a wide variance is essential for authentication and reliability of extended compliance consultation. However, consultancy services to these fields come with a number of challenges. Few of them are to achieve certification standards, making robust changes with changing compliance, and heavy investments in R&D & infrastructure. The industry therefore needs a functional organizational structure conceptualizing and balancing regulatory compliance with reliable consultant in market.
Neozenith Consulting Services, a company established in 2016, is a complete consulting service provider to Pharma, Cosmetic, Ayurvedic, Medical devices, Food, primary packaging material and other allied industries. The company’s operations are managed by Dr. Gautam Sharma who explains the extent of the ‘One-stop complete solution’ service by Neozenith. He says, “Neozenith Consulting Services is an organization that deals with the pharmaceutical consultancy, regulatory submission, QMS & GMP implementation, facility designing and updation, qualification & validation, clean room engineering, greenfield project, WHO-GMP certification, WHO-GDP certification, MDR, MDSAP, EXCiPACT certification, training, ISO certifications, BRC certifications, customer & vendor audit compliances and modification of present facility as per current requirement of the standard and regulatory bodies”.
Consulting Is More Than Giving Advice
To eliminate waste of time, money and resources, clients need a better understanding of what consulting assignments can accomplish. They need to ask more from such advisers, who in turn can advise them as well as go hand-in-hand with them to satisfy expanded expectations. We have designed our company to simplify and speed-up the regulatory compliance. Our work culture makes Neozenith unique, valuable and different. We are fully committed organisation in regulatory profession and its practitioners. We help our customers to lead in regulatory compliance. We support them to meet regulatory challenges of the present and future. We are really focused on driving regulatory excellence at all levels.
Preventing & Resolving Compliance Problems
Dr. Gautam encapsulates the service range of Neozenith in a nut-shell – “Neozenith helps organizations prevent and resolve compliance problems and to develop efficient and effective strategies for the submission and approval of drugs, devices, and primary packaging material”. Its concept of operating is an ideal state-of-the-art solution for manufacturing companies. The USP of Neozenith’s products and services is a high-quality range that is both time and money-saving. While serving its customers, Neozenith stands-out in its performance of assisting them.
One of the major services is regulatory compliance services and certifications. The sectors that Neozenith deals with are companies like pharmaceutical (API, Excipient, intermediates & Formulations), primary packaging material manufacturer, food manufacturing, medical devices manufacturing, PPE manufacturing, and more. This industry sector is driven by customer-focused operations. Keeping this insight, Neozenith supports the client companies to achieve ISO 9001, ISO 13485, ISO 15378, ISO 22000, ISO 14001, ISO 45001, ISO 22716, BRC, EXCiPACT, WHO-GMP, WHO- GDP, NABH, NABL, 21 CFR Compliances, MDR, MDSAP, CE Certification, and regulatory certification. Their next major area of service is a consultation, where the company provides guidelines to the companies for cGMP implementation. The Employees of Neozenith are skilled in identifying our client issue and offer visible solutions through regular site visits and extensive communication.
Neozenith has another important service spectrum for their clients that include designing cleanroom engineering and facility design. Its turnkey solutions for cleanroom engineering, with best Air Modular System along with HVAC system equipment are adapted to the latest technology and design. This is effective for the client companies to gain ISO certification and maintain regulatory compliance for a long period.
Consultants For Exponential Expansion
Neozenith’s track has proven it to be a classic consultant for critical issues and key
opportunities. Its spectrum of consultation includes Strategy, Technology, Corporate Finance, Marketing, Organization, Performance Improvement, Transformation, Sustainability and Optimum Result Delivery. Neozenith is an expert in Green Field projects for pharma and medical device enterprises. It is renowned for pharma packaging along with its presence in API and food industries. The company has the ability to perform GMP implementation at manufacturing and GDP implementation at warehouses, along with QA and QC compliance testing.
Neozenith’s testing is all adhered to SOPs and protocols. The company is also an expert in Auditing, Monitoring of internal and external audits, Vendor development (Audit, Evaluation & Approvals), Staffing & Training and Validations & Qualifications. Dr. Gautam adds, “Across all industries and geographies, we bring deep, functional expertise but we are known for our holistic perspective”. We capture value across boundaries and between the silos of any organization’s management. We provide consultancy & services to the clients to conceptualize and visualize technology-driven business transformation initiatives”.
Neozenith has a versatile service range inclusive of Project Management, Analytical Method Development, New Product Packaging & Development, Facility Design, Equipment Validation, Drug Product Development, cGMP documentation, GMP/GLP personal hygiene practices, and GDP Documentation. Dr. Gautam says, “We provide assistance in Medical device and food facility registration with USFDA and other regulatory bodies, and help to comply with their requirements. We are associated with India air modular systems provider for engineering and design, with the latest design and technology, high-quality range with an ideal line of products and services that would save your money and time”.
Excipact Certification
This certification makes excipient manufacturer to stand-out from the crowd in market. This certification is for pharmaceutical excipient manufacture, storage, and distribution (which include repacking & relabelling and warehousing in original containers). Other materials used in the manufacture of pharmaceuticals, or their starting materials that require the same standards of GMP and GDP. Neozenith targets excipient manufacturer in India to comply with this standard and to make India in leading manufacturer of excipient.
Skill Development Training
In this program, Neozenith targets all Graduate/Post Graduate students, where it provides training to them according to their key of interest to entre in pharmaceutical industries. This program helps to fill the gap between industries accepted standards and student expertise. The main aim of Neozenith with this program is to train and prepare the students to get placement in pharmaceutical companies.
We have been working for pharmaceutical, primary packaging, medical device, excipient, and cosmetic manufacturing companies with an excellent track record for the best customer satisfaction and regulatory compliance
MDSAP: Medical Device Single Audit Program
MDSAP was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of quality management systems (QMS). The MDSAP audit is based on approved Auditing Organizations undertaking an audit of ISO 13485- Medical devices- Quality management systems- Requirements for regulatory purposes. The applicable regulatory requirements of the participating jurisdictions – Australia, Canada, Japan, Brazil, US – are also included as areas of focus. Although the audit model used for MDSAP does not incorporate the requirements from the European regulations, the MDSAP audit report form was developed so that it can be used for multipurpose audits. Where an Auditing Organization is also a notified body for the European Regulations, there is obvious interest in incorporating European requirements into the MDSAP audit criteria to combine the audit activities and eliminate duplicate reporting.
Team Commitment
Neozenith has distinctive skills and extensive knowledge in Quality, Formulation, Manufacturing, Regulatory Affairs, Process Development, and Packaging & Labelling of clinical and commercial suppliers to achieve optimum satisfaction for clients. The team of experts at Neozenith is committed to providing its client unique and unparalleled consumer experiences and satisfaction. Dr. Gautam says, “We have been working for pharmaceutical, primary packaging, medical device, excipient, and cosmetic manufacturing companies with an excellent track record for the best customer satisfaction and regulatory compliance. We have never compromised on the quality and the services provided to the customer. We believe in keeping the customers happy and providing them with the services at a very competent price”.
Neozenith aids its clients in resolving compliance issues and developing effective strategies for proper submission presentations for drug, product and medical device approval. It works with a team of highly experienced consultants to provide individual client guidance to ensure the best outcome as the project results. The company deals with a diverse client range with stringent quality tests for pharmaceuticals, primary packaging material, excipients and medical devices in taking transformation initiatives driven at the core by technology. Its expansive service profile and competency in handling a wide variety of industrial requirements for pharmaceutical, primary packaging, medical device, excipients, and others, make it a one-stop-shop. Ease of accessibility and precise consultation for expanding business and maintaining stringent quality benchmarks to optimize productivity distinguishes Neozenith from various service providers.
Looking At The Future
Dr. Gautam says, “We take pride in providing, above all else, reliable guidance to clients of all sizes. Our clients range from small start-ups to known pharmaceutical, medical device, food, and Pharma packaging firms. The hallmark of our success has been our outstanding customer satisfaction and client retention”. The future landscape of company operations includes a commitment of the entire workforce to strive for unparalleled customer service.
Dr. Gautam’s words are inspiring for the entire workforce that strives to meet the clients’ demands. One important step towards such function is inducing continuous total quality management and training to go hand in hand as per Dr. Gautam’s vision. He says, “Neozenith will fulfill its mission through the application of its unique skills and expert knowledge in the fields of quality, regulatory affairs, formulations, process development, manufacturing, medical device, packaging, and labelling of clinical and commercial supplies, as well as staffing and training”. Hence, Neozenith is all set to emerge as a leading service provider in the world of Consultancy.
