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Ophthalmic Formulation

Reliable Ophthalmic Drug Formulation Development

Establish your optimal ophthalmic formulation by identifying the best-suited delivery method and creating a well-balanced dosage form with our team. Whether your drug takes form as a solution, suspension, ointment, or emulsion, our experts are ready to help you take your program to clinical phases through commercialization. Our team keeps scalability in mind while ensuring sterility and microbe-resistance every step of the way.

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Formulation Development

Small Batch API

In early-stage research, overcoming limitations related to the availability of your active pharmaceutical ingredient (API) can be challenging. Our approach allows you to strike a balance between advancing your program and addressing these constraints. We have a track record of achieving exceptionally high yields without compromising quality, even when working with limited quantities of API material. Our solutions and capacity to produce small batch sizes not only help conserve your API, but also result in time and cost savings for your project.

IND Application Batch Records

Meet your clinical requirements and fulfill regulatory standards with our diligent record keeping. Our batch records accurately outline and document the steps needed to manufacture your product for clinical use. These records are needed for the Chemistry, Manufacturing and Control (CMC) section of your Investigational New Drug (IND) Application.

Aseptic Fill-finish

Be confident in the quality and compliance of your clinical supplies by partnering with us for development and manufacturing. Our state-of-the-art aseptic fill-finish manufacturing facility meets FDA, cGMP, and EU requirements for Phase I and II clinical trial products. Our sterile fill facility is monitored, controlled, and recorded in real-time and serviced with our own Water for Injection (WFI) system.

Our facility’s HVAC system uses 99.99% efficiency HEPA (High-Efficiency Particulate Air) filters. It is housed in an easily serviced mezzanine above the fill suite and below our roof, eliminating weather-related malfunctions.

Bottles & Vial Selection

Streamline your development with validated bottles and vials available at significant savings. Ophthalmic bottle sizes covered by our validated media fills include 1cc, 3cc, and 7.5cc. Parenteral vial sizes covered by our validated media fills include 2mL, 5mL, 10mL, and 20m

Integrated Laboratory Services  

Our team of experts is ready to support your project at any stage in the process. Be sure to check out our additional offerings.