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WESTERN

Western BioPharma Services is a US based company that provides a wide range of services to Pharmaceutical and Biotechnological companies across the globe in developing FDA approvable therapeutic products and their conversion into EU & Health Canada applications. We can act as your organizational US agent with FDA. We specialize in US Regulatory, Chemistry Manufacturing and Controls (CMC), Regulatory CMC, Regulatory-Medical and Scientific Writing, Pharmacometrics, Clinical Development, Quality Assurance and Compliance. Our team consists of highly skilled and experienced professionals who are dedicated to delivering innovative and high-quality services and solutions to our clients. We understand that science is constantly evolving, and we strive to stay ahead of the curve by continuously learning and adapting to the latest innovations, ICH, US FDA, EU and Health Canada guidelines. At Western BioPharma, we take a client-centric approach to our work. We work closely with our clients to understand their projects, challenges, and organizational goals. We believe in building long-term relationships with our clients by consistently delivering value and quality.

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Pharmaceuticals

Western BioPharma team’s wealth of experience has resulted in multiple drug approvals with FDA. Western can be your strategic partner for small molecule and peptide projects. Western can provide regulatory and developmental services from discovery through NDA approval for new drugs [505(b)(1) and 505(b)(2) NDA pathway]. We can guide our clients on wider range of therapeutics areas and dosage forms.

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Generics

Time and money are critical in Generic Drug Development especially in first-to-file products to receive 180-day marketing exclusivity. Well-designed regulatory strategy and guidance is paramount in approval of an ANDA application in its first attempt. Western BioPharma takes pride in team’s experience in many successful generic drug approvals in first round. We can leverage our regulatory and CMC experience across ample of ANDA applications over various dosages forms in guiding clients on strategy, required data, regulatory gaps, and dossier quality.

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Biologics

Biologics have exciting possibilities in treating several unmet medical conditions and biologics industry forecasted a significant growth. Biologics present unique developmental challenges and regulatory requirements. Western BioPharma can support you in custom designing your project specific developmental and regulatory path for a successful application at FDA. Western BioPharma group has expertise and experience in providing regulatory and developmental services for biologics including cell and gene therapies, human cell and tissue products, monoclonal antibodies, antibody-drug conjugates, protein therapies and biosimilars.

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