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A TRUST WORTHY COMPANY.
A RELIABLE & SUSTAINABLE PARTNER
UL Biopharma is a Mumbai based pharmaceutical management consulting focused on Pharmaceutical sciences, Biotechnology and Life sciences. We provide robust technical and commercial due diligence support from R&D to supply chain, and from every facet of operations to commercialization, asserting excellence at every stage of pharmaceutical value chain. We serve a critical role in guiding new pharmaceutical projects and improving processes and operations, thereby creating a competitive edge through unique solutions. Our customized approach combines deep insight into the dynamics of the companies and offer expert advice at all levels of the client organisation. We ensure that our clients achieve sustainable competitive advantage, build more capable organisation and secure lasting impact in the changing pharmaceutical landscape, enabling success together with passion and trust. We are a leading pharmaceutical consultancy firm specializing in providing end-to-end services, guiding companies through the entire process from concept to commissioning of pharmaceutical manufacturing facilities. With our deep industry knowledge, expertise, and commitment to excellence, we offer comprehensive solutions tailored to meet our clients' unique needs. Here's an overview of our company and the services we provide:
At UL BIOPHARMA, we are dedicated to partnering with pharmaceutical companies to turn their vision into reality. UL Biopharma team is experienced professionals, including project & process engineers, pharmaceutical chemists, biotechnologists, microbiologists, Quality assurance, analytical, and regulatory experts, to successfully navigate the complexities of setting up a pharmaceutical manufacturing facility.
Our Approach:
We take a client-centric approach, understanding that each project is unique and requires personalized attention. Our team works closely with clients to identify their goals, requirements, and challenges. By collaborating closely and leveraging our extensive industry experience, we develop tailored strategies and solutions that ensure successful project execution.
Salient features of our Service Offering:
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Concept Development: We assist clients in shaping their concepts by conducting feasibility studies, market research, and strategic planning. Our experts analyze market demand, assess regulatory considerations, and provide insights that form the basis of a solid project concept.
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Facility Design and Engineering: Our team of engineers and architects develop comprehensive facility designs and engineering plans, incorporating the latest industry standards, regulatory guidelines, and best practices. We focus on optimizing operational efficiency, ensuring compliance, and creating a safe working environment.
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Regulatory Compliance: We provide regulatory expertise, ensuring that all aspects of the pharmaceutical facility, including design, processes, documentation, and quality systems, meet the stringent requirements of regulatory authorities. Our consultants assist in obtaining necessary licenses, permits, and certifications.
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Project Management: Our experienced project managers take charge of the entire project, ensuring effective coordination, resource management, and timely execution. We employ proven project management methodologies to monitor progress, mitigate risks, and keep the project on track within budget and schedule.
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Equipment Selection and Procurement: We assist in selecting the most suitable equipment and technology for the pharmaceutical facility, considering factors such as quality, efficiency, scalability, and compliance. Our network of trusted suppliers enables us to source high-quality equipment at competitive prices.
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Validation and Qualification: We offer comprehensive validation and qualification services, ensuring that the facility, equipment, processes, and systems meet regulatory requirements. Our experts develop validation protocols, execute validation activities, and provide detailed documentation to support compliance.
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Training and Knowledge Transfer: We provide customized training programs for personnel involved in operating the pharmaceutical facility. Our training covers topics such as good manufacturing practices, standard operating procedures, safety protocols, and regulatory compliance, enabling smooth operations and adherence to industry standards.
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Commissioning and Start-up: Our team oversees the commissioning and start-up process, ensuring a seamless transition from construction to operational phase. We conduct thorough testing, equipment integration, and performance evaluations to ensure the facility is ready for production.
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Post-Commissioning Support: We offer ongoing support services, including maintenance, process optimization, regulatory updates, and periodic audits to ensure the long-term success and compliance of the pharmaceutical facility.
At UL Biopharma, we are committed to delivering exceptional results, providing our clients with the expertise, guidance, and support they need to establish world-class pharmaceutical manufacturing facilities. With our comprehensive service offering, we aim to contribute to the growth and success of our clients' businesses in the pharmaceutical industry.
Our team
Dr Umesh Luthra
Fermentation Professional with General Management knowledge having about 28 yearsof Industrial experience in Research and Development, Project and Production. Having good exposure in establishing DSIR approved research and development lab for Biotech & API. Proven abilities in Technology Transfer, scale up, process optimization, stabilization of yield and enhancing the productivity. A Challenging leader with excellent problem solving, critical thinking, planning and management skills and completes the Production task in time. Worked on different Primary and Secondary metabolites of following therapeutic segments: Antibiotics, Statins, Anti-cholesterol & Anti-obesity, Immunosuppressant, Antifungal, Oncology, Enzymes, Vitamins, Nutraceuticals, Steroids and Hormones. Having experience on Green field projects starting from conceptual design, detailed engineering, commissioning and qualification of plant. Excellence in identifying opportunities for cost improvement to improve the bottom line. Ample experience in scale up to pilot scale and then successfully to production scale of different capacities such as 10 KL, 30 KL, 50 KL and 100 KL from the R & D.Managed and overseen the production scale activities which involved Fermentation, Downstream and Purification, Quality Control, Effluent treatment plant and Engineering. Having good experience in trouble shooting of production issues related to Microbiology / Fermentation / Downstream & Purification / QC / QA / ETP/ Warehouse / Engineering.Worked with few pharma companies: Max-GB, Kopran Drugs, GTBL, Krebs Biochemical, Fulford India, IPCA, and Accord Life Spec – Teyro Labs
Dr Vandana Gupte
An enthusiastic and dynamic pharmaceutical professional with more than 30 years of experience, dedicated to driving excellence in pharmaceutical development for quality compliance and regulatory affairs. With a solid foundation in analytical sciences, process knowledge and management core competencies like research, technology transfer, and operations, she has excellence in managing complex projects and delivering tangible results. Her expertise lies in pharma analytical research and development, technology transfer, regulatory compliance and training. She has several years of experience leading technical teams and project goals with deep understanding of current pharmaceutical trends and development
Dr. Vijay Ozha
Having vast experience of 33 yrs In API R&D, Regulatory Affairs and Audits, He was Gold Medallist of Rohilkhand University, Bareilly and obtained his PhD Degree from one of the elite pharma institutes, Central Drug Research Institute, Lucknow. Hands-on experience in TTD (Technology Transfer Document) preparation, technology transfer to pilot and commercial scale. Worked with Ranbaxy Laboratories, Lupin Labs, Ipca Laboratories, Fresienious Kabi Oncology Ltd, Flavin and Uni Drug.
Mr. Nishith Pathak
Expertise in designing, installation and commissioning of API Manufacturing Plant. Good exposure in acquiring all necessary government licenses to manufacture API. Hands-on experience in TTD (Technology Transfer Document) for Biotech & Synthetic API, and ensuring the Technology at Pilot Plant. Well versed with the successful transfer of technology to commercial scale up batches and assimilation of the process and other aspects thoroughly while implementation of new products / technologies at the plant for optimum output and quality standards. Strong hold on designing and implementation of Quality Systems and Regulatory compliances. Good ability in reviewing technology transfer documents, Product Development Report, Drug Master Formula (DMF), specifications of raw materials, packing materials, water and finished goods.
Dr. Ashvini K Saxena
An enthusiastic and dynamic pharmaceutical professional with more than 35 years of experience in Research and Development, Project and Production. Practical process development for hassle free translation in Pilot plant & Commercial Plant. Have hands on experience in scale up of complex processes. Great exposure in cost reduction of potential products. Well aware of Capacity utilization & Capacity enhancement through debottlenecking. Good understanding of customer requirements and fulfilling the same to the satisfaction of the customers. Apt at driving growth with introduction and commercialization of new products. Have good experience in solving challenging operational and process issues. Operational excellence and timely delivery of goods as well as development of APIs.
Mr. Ravindra Barhate
He is a graduate in chemistry, post graduate in Software Development and system analysis and has completed post graduate diploma in Drug Regulatory Affairs and Pharmaceutical Quality Assurance Management. He is having 30+ years of experience in Quality Assurance in various pharmaceutical companies (APIs as well as formulations) in India and abroad. He is also having experience of setting up green field formulation and API manufacturing facility including conceptual designing, detailed engineering, commissioning and qualification of equipment/systems. He is experienced in preparation for regulatory inspection and monitoring compliance. He has faced various regulatory audits including USFDA, UK-MHRA, WHO-Geneva, IDA-Netherland, EU, MCC-South Africa, MOH-Russia etc. He is having experience of technology transfer of APIs as well as formulation products. He is expert in computer system validation. He is experienced in third party vendor audits on behalf of various national and international pharmaceutical manufacturing companies. During his career he handled various dosage forms like Tablets, Capsules (soft gelatine as well as hard gelatine), Injections SVP (Powder as well as liquid), Oral liquids, Ointments and APIs. He is also a software programmer and has developed various softwares useful for Quality functions in pharmaceutical manufacturing companies.
Mr. Sunil Kulkarni
A strategic professional over 28 years of experience in spearheading in Mechanical Project Management, Erection, Installation & Commissioning, and Operations & Maintenance of plant & machinery while meeting business needs in a fast paced, dynamic and globally expanding MNC environment. Enterprising leader with a strong record of contributions that invigorated businesses, heightened productivity & enhanced internal controls by improving maintenance, energy, cost & EHS performance, machine utilization and quality performance. He is having great experience in enhancing the production & process operations, optimizing resource & capacity utilization; escalating productivity & operational efficiencies. Have good skills in devising strategic plans & schedules for project activities, USFDA Practices with focus on optimum utilization of manpower & materials. He is an effective leader with excellent communication, negotiation and relationship building skills and can handle / co-ordinate multiple projects. Independently can do the basic detail engineering calculation.
Mr Satessh Singh is a Chemistry graduate and MBA in marketing. He has close to three decades experience in domestic marketing and sales in Pharmaceutical industry. He has handled a vast team of 1000 Cr plus turnover. He is subject matter expert in pharma marketing and sales.