Consulting Services

One Health. One Mission.

Supporting both human health and animal health life science companies around the globe.

With a team experienced in both FDA-CDER and FDA-CVM product development and management, no product or opportunity is off limits. Our regulatory and technical services extend across industries.

Human Health

Whether it's an NDA, ANDA or 505(b)(2) project. Our team can support you to the finish line. Engage our team today to discuss how we can become a part of your team.

Animal Health

We're here to support your INAD, ANADA or diagnostic endeavor. Our team can help design the right product for the animal health market, and support you through the entire FDA-CVM approval process.

What We Do

Drug Development

At Cypress Bioscience we cater to all stages of the pharmaceutical product development. From formulation to filing, our approach to product development and regulatory strategy focuses on one thing-- achieving FDA approval and commercializing a finished product.

With decades of experience engaging FDA, our team looks for creative and cost efficient development solutions to satisfy FDA requirements and provide the market a safe and effective drug product.

Regulatory Compliance

Pharmaceutical quality and regulatory compliance are a must to maintain business growth and operate within the jurisdiction of FDA oversight.

At Cypress Bioscience, we can support your current quality systems or design a program that fits your business model from scratch. From implementing Standard Operating Procedures, to FDA audit preparation, or State license support, our team can manage your compliance and quality assurance needs.

Electronic Submissions

Communicating with FDA is a time consuming and technically demanding task.

Our team at Cypress Bioscience have the experience and knowledge when is comes to dossier formatting and electronic communications with FDA. From original application filings, to CBE or PAS changes, concise and organized eCTD document compilation is a must to get your information in front of FDA. Whatever your electronic submission needs, we've got you covered.

Post Approval Management

Regulatory compliance enters a new phase when your product gets approved. Maintaining adequate and thorough technical information for FDA ensures your product will remain in good standing. Our team can support your post approval reporting needs, manage pharmacovigilence and more. So you can stay focused on growing your business.›