In our Commercial division, we offer a comprehensive range of services to support the successful commercialization of pharmaceutical products. We understand the critical importance of process validation, ensuring that the manufacturing process consistently produces products of the highest quality. Our team of experts works closely with clients to develop and implement robust validation strategies.
With our state-of-the-art facilities and expertise in large-scale manufacturing, we have the capability to handle multi-ton commercial manufacturing. We have a proven track record of delivering high-quality products in large quantities, meeting the demands of global markets.
Regulatory compliance is a top priority for us. We provide global regulatory filing and support services, guiding clients through the complex regulatory landscape to obtain timely approvals for their products. Our team has extensive experience working with regulatory authorities worldwide, ensuring smooth and efficient interactions throughout the filing and approval process.
Stability studies are essential to assess the shelf life and product quality over time. We conduct comprehensive stability studies, following regulatory guidelines, to provide valuable data on product stability under various storage conditions. This information is vital for establishing appropriate storage and handling requirements and ensuring product integrity.
We understand the challenges associated with shipping pharmaceutical products to global markets. Our logistics team ensures hassle-free shipments, employing robust supply chain management practices to safeguard product integrity and timely delivery.
Formulation support is another key aspect of our Commercial services. Our experts collaborate with clients to optimize the formulation of their products, considering factors such as stability, bioavailability, and patient compliance. We leverage our formulation expertise to develop innovative and effective dosage forms that meet the specific needs of the market.
For clients pursuing Drug Master File (DMF) and Abbreviated New Drug Application (ANDA) filings, we provide comprehensive support. Our regulatory experts assist in preparing and submitting DMFs and ANDAs, ensuring compliance with regulatory requirements and maximizing the chances of successful filings.
At our Commercial division, we are committed to delivering high-quality pharmaceutical products to global markets. Through our expertise in process validation, large-scale manufacturing, regulatory support, stability studies, formulation support, and DMF/ANDA filing assistance, we aim to provide our clients with a seamless and successful commercialization journey.
Our comprehensive CDMO capabilities and state-of-the-art facilities enable us to provide a wide range of services to meet your pharmaceutical needs. With our end-to-end service approach, we focus on delivering tangible results and meeting project milestones. Our program management ensures efficient coordination and execution of projects. We have a robust quality management system in place, ensuring that our processes adhere to the highest standards of quality. We prioritize health, safety, and environmental considerations in all our operations. Data integrity and intellectual property management are core aspects of our business, ensuring confidentiality and protection of your valuable information. We offer two distinct business models to accommodate different partnership requirements.
At Teadus Pharma, our goal is to provide our clients with exceptional technical expertise, grounded in our specialist chemistry knowledge and robust project management capabilities. We are committed to delivering excellence, guided by internationally recognized ethical and quality standards.
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