Technical Advisors for API (Chemical, Biochemical & Nutraceuticals) & Formulation
We are consultants for end to end Pharma project requirements:
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Turnkey project solutions from Green field to commissioning of facility including conceptual design, detailed engineering, and execution of project meeting global regulatory requirements (cGMP, WHO-GMP, USFDA, EU, MHRA, ANVISA, ISO, TGA Etc.)
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Process Technology for APIs & Formulations from India & China which are most cost competitive & qualified as to stringent FDA norms, with execution/transfer support.
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Regulatory filing and compliance support to small & medium scale pharmaceuticals for DMF, FP dossiers.
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Licensing of FDA registered / approved dossiers in India, US, EU, Anvisa etc.
About us
UL Biopharma is a Mumbai based consulting firm focused on Pharmaceutical, Biotechnology and nutraceuticals. We provide end to end solutions for pharma projects, setting up R&D and manufacturing plants, Process technology outsourcing & transfer to commercial levels, and Regulatory & compliance ...................
Services
We offer end to end consultancy services in
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Plant Design and Scale up
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Engineering Inputs and Advice
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Technology transfer
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Process Improvements
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Technology licensing
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Regulatory filing & Compliance
Projects
Highly experienced team of experts provides consolidated technical & administrative support to manufacturing & CDMO companies operating anywhere in the world. We have established a strong network and built up a competitive team offering their expert knowledge for a number of national and international companies on various levels..
Our Services
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Conceptual Design
The first step to a project is conceptualization which is based on User Requirement Specification (URS). We understand the critical role that efficient and well-designed pharmaceutical plants play in ensuring the production of drugs in most efficient manner. Our approach begins with a thorough analysis of our clients' objectives, considering factors such as production capacity, product portfolio, regulatory landscape, and market dynamics.
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Detailed feasibility plan
After the approval of basic conceptual design based on interaction with client, we work closely with our clients to develop a comprehensive project design that encompasses facility layout, process flow, equipment selection, automation systems, and environmental considerations. We leverage our deep expertise in pharmaceutical plant design and our extensive network of industry partners to provide holistic solutions. Our consultancy services extend beyond conceptual design to encompass project planning, resource allocation, risk assessment, and budget management. We pride ourselves on delivering practical solutions that balance operational efficiency, cost-effectiveness, and sustainability.
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Project Execution
We work closely with our clients to develop a detailed project execution plan that addresses all aspects of the pharmaceutical plant construction, including civil work, architectural design, mechanical and electrical installations, and regulatory compliance. Our services include:
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Site Assessment and Preparation: We conduct a thorough analysis of the proposed site to assess its suitability for the pharmaceutical plant. This involves evaluating factors such as land quality, topography, infrastructure availability, and environmental impact.
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Architectural Design and Engineering: Our team collaborates with experienced architects and engineers to develop a functional and aesthetically pleasing design for the pharmaceutical plant. We ensure that the design optimizes space utilization, meets regulatory requirements, and incorporates industry best practices.
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Structural Construction: We manage and oversee the construction of the plant's structural components, including foundations, walls, floors, roofs, and other load-bearing elements. Our team ensures that all construction activities adhere to approved plans, comply with safety regulations, and meet quality standards.
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Utilities and Services: We coordinate the installation and integration of essential utilities and services, such as water supply, HVAC (heating, ventilation, and air conditioning), electrical systems, plumbing, and waste management. Our experts ensure that these systems are designed and implemented to support the plant's operational needs efficiently.
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Compliance and Regulatory Requirements: We provide guidance and support to ensure that the construction of the pharmaceutical plant complies with relevant building codes, industry regulations, and environmental standards. We assist in obtaining necessary permits and certifications and conduct regular inspections to ensure ongoing compliance throughout the project.
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Qualification
With a team of highly skilled experts and a deep understanding of regulatory requirements, we offer a wide range of services tailored to meet the unique needs of pharmaceutical companies seeking to achieve compliance, operational excellence, and product quality assurance. We assists our clients for preparing the area & equipment Qualification Master Plan (QMP) Development and qualification protocols, IQ, OQ & PQ etc
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Commissioning
We finally get the facility inspection, certification and approval. With a strong focus on regulatory compliance, quality assurance, and operational efficiency, our experienced team is committed to guiding pharmaceutical companies through the critical phase of facility commissioning to ensure successful project implementation. Services include Commissioning Master Plan Development, System Identification and Prioritization, Commissioning Protocol Development and Execution, Risk Assessment and Mitigation, Equipment Verification and Calibration, Facility Utility Qualification etc..
C-402, Saichitra building, Charkop Sector 8, Kandivali west, Mumbai 400 0067
+91-9167759646
Technical consultants for pharmaceutical projects | Setting up R&D & Plant - API & Formulation technology offering and demonstration | Turnkey project from green field to commissioning