Biotechlogic

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Description

BioTechLogic has extensive experience in providing CMC Regulatory Services and is looking forward to discussing the latest news from the program.

BioTechLogic has experience in the design of unit operations. We provide knowledge and experience using various equipment and operating procedures, and consider validation requirements in the decision-making process.

BioTechLogic has over 17 years of experience in drug product manufacturing experience throughout the United States and Europe. Our production expertise includes compounding, sterile filtration, component and equipment preparation, aseptic filling and stoppering, lyophilization, capping, labeling and packaging operations. We have supported and managed drug product production for various biologic compounds including PEGylated proteins, PEGylated antibody fragments, vaccines, blood products and other recombinant proteins in various forms of delivery (liquid, lyophilized products, suspensions).

BioTechLogic has provided project management leadership for virtual, mid-size and large biopharmaceutical companies that have required experience in the commercialization of a biologic or oligonucleotide compound for registration in the United States, Europe, Canada and other countries. Our experience has included project management for entire project plans, as well as management of regulatory submissions, pre-approval inspection readiness programs and process validation efforts. Our global product registration experience allows us to quickly identify risks and offer proven solutions.

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