Unique challenges, customized support
Our Passion
ACI Biosciences team members are highly skilled in veterinary medicine, pharmacology, immunology, project management, manufacturing process development, and regulatory affairs.
ACI Biosciences has engaged professionals with deep experience in the development of regulated pharmaceutical and biologic products. Whether creating a new product development plan with accompanying costs and timeline; providing regulatory guidance, representation, and submissions; pharmacokinetics/ pharmacodynamics analyses; the conduct of a single study; or a full development program, ACI Biosciences partners with Sponsors to help achieve their goals.
ACI Biosciences operates under a robust Quality Management System, providing comprehensive SOPs; investigational site selection and training; quality audits of clinics, CROs, laboratories, documentation, and processes; and extensive vendor qualification.
ACI Biosciences team members are highly skilled in veterinary medicine, pharmacology, immunology, project management, manufacturing process development, and regulatory affairs.
ACI Biosciences has engaged professionals with deep experience in the development of regulated pharmaceutical and biologic products. Whether creating a new product development plan with accompanying costs and timeline; providing regulatory guidance, representation, and submissions; pharmacokinetics/ pharmacodynamics analyses; the conduct of a single study; or a full development program, ACI Biosciences partners with Sponsors to help achieve their goals.
ACI Biosciences operates under a robust Quality Management System, providing comprehensive SOPs; investigational site selection and training; quality audits of clinics, CROs, laboratories, documentation, and processes; and extensive vendor qualification.
STUDY CONDUCT
We support the creation of new treatment options for complex medical conditions through our engaged network of veterinarians, and their clients.
Our Study Teams are highly trained to manage Good Clinical Practice (GCP) and non-GCP clinical field studies effectively and securely, meeting the most rigorous standards for each market, product type, or regulating agency.
Our Marketing Team works to improve enrollment rates and expand opportunities for pets and veterinarians and their staff to participate in clinical studies by enhancing the study profile in the professional community and on social media platforms.
WELFARE
Our Animal Care and Use Committee evaluates and provides an ethical review for all studies performed by ACI Biosciences, as well as on a contract basis for non-ACI studies.
Years of development experience
Getting to approval, getting to market
New Product Development is both an art and a science, and the milestones of regulatory approval and product launch are years and millions in the making. Our shared goal is to integrate into your development team to provide the right expertise at the right time, but we also will tell you when we are not the right fit or cannot help, and aim to introduce you to colleagues who can.
Our work is conducted primarily in North America, with evolving, proprietary capabilities in Brazil and with development partners in Europe, Australia, and Japan.
If capabilities align, ACI Biosciences may contribute to new product development plans, study design and implementation for production animals.
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Schedule a call, and we’ll answer your questions and discuss next steps.