UL Biopharma

Setting up R&D & Plant

We specialize in guiding pharmaceutical organizations through the intricacies of establishing state-of-the-art R&D labs,ensuring they meet industry standards, regulatory requirements, and maximize research productivity. We bring together a team of experienced professionals who possess a deep understanding of the pharma industry, advanced laboratory technologies, and best practices in research management.

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Plant Design and Scale up

The consultancy services are also available for

• Designing pilot and commercial scale plant (Multi-product or custom).

• Small scale fermenter setup i.e., from 10 to 100 L.

• Pilot plant design and sizing based on the process or multi-product facility design.

• Industrial Fermenter design and facility.

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API & Formulation Technology

UL Biopharma is offering end to end product development, manufacturing services and innovative products for biotech and pharma. We bring technologies with competitive advantage and these services are part of the solution bringing your project one step closer to success.
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We can provide technology for API manufacturing that is very cost competitive to Indian & Chinese manufacturers as well as formulation compositions & processes for India, and regulated markets. We have a portfolio of over 100 SKUs that can be explored for scaling your business. We provide complete project visibility on profitability in current market set-up and we are not just advocates of providing the paper technology, but we do hand-hold your team for execution to the defined target or provide our manpower to demonstrate from lab scale to commercial scale.  Pl. connect with us for more information . 

Technology Transfer

The delivery and implementation of projects is done at the client site by our team. Demonstration of process can be done at client site, our site or technology provider site or an outsourced lab.

Complete knowhow about the strain of microorganism, fermentation process, laboratory procedures, downstream purification, piloting and commercial setup are assured during technology transfer. Our technical staff and scientists with relevant industrial experience are committed to support the client at their site to achieve their goals within stipulated timelines meeting product quality to global standards & pharmacopeias .

Our services are available for the following categories:

• Nutraceuticals, Amino Acids, Enzymes, Caratenoids, Vitamins

• Steroids & Hormones,

• Antimicrobials, Antibiotics, antifungal & Immunosuppressants

• Anti-cholesterol, Anti-obesity, Antidiabetic Gliptins & Gliflozins

• Anticancer/ Oncology etc..

Regulatory dossier support

A salient and exclusive feature of our service is to provide end-to-end support that include dossier compilation & regulatory filing assistance. If your company has limited internal resources for a full-fledged regulatory team or expertise in dossier compilation as per US DMF, CEP, WHO DMF, CADIFA, ANDA etc, we bring such expertise as part of our service package. We assist not only for filing your product dossiers, but also guide in addressing regulatory gaps or queries on submitted dossier. 
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Our experts can guide on different filings requirements like new NDA, 505(b)(2) NDA, paragraph IV projects for USA, We assist in planning your development starting from pre-clinical, clinical, toxicology, and CMC data generation as per EMA, and US FDA guidance. 

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Pl. connect with us to discuss your project