On-Demand Webinar: Formulation Strategies for Early Clinical Phase Studies
Pace Analytical Life Sciences, LLC has decades of practical formulation experience and expertise with sterile products (solutions, suspensions, emulsions, gels and lyophilized powders) and non-sterile oral / topical dosages (tablets, capsules, solutions, suspensions, and semi-solids). Pace Analytical Life Sciences, LLC approaches each formulation project with the eventual commercial product in mind.
We specialize in developing effective and robust formulations that are:
Bioavailable: Effectively preserve the API and control the delivery through the intended route of administration.
Non-toxic: Meet the unique requirements to ensure the product is safe, tolerable to the patient, and comfortable at the site of administration by controlling key variables, such as pH and Osmolality.
Manufacturable: Compatible with technologies and processes within Pace Analytical Life Sciences, LLC and scalable to a wide range of standard processes available within commercial CMOs.
Chemically and Physically Stable: Effectively preserve the API throughout the manufacturing process, distribution, product shelf life, and administration.
Our formulation development services include:
Excipient Compatibility Studies: Our experience with a wide range of dosage forms, to include ophthalmics and parenterals, helps our clients develop formulations that work within the clinic and withstand the increased rigor of today’s regulated environment.
Formulation studies: QBD studies are designed with attention to every detail from use of GRAS ingredients, to identification of potential stability problems, compatibility with container/closure systems and stability of the API under the conditions of pharmaceutical manufacturing.
This attention to detail helps us create an appropriate formulation for your product that is safe, pure and effective. It will withstand FDA scrutiny and accelerate the successful commercialization and launch of your product.