CMC Pharma offers comprehensive pharmaceutical development services designed to accelerate your programs while reducing risk. Our integrated approach spans formulation and process development, analytical method development, stability and compatibility testing, and method transfer execution, ensuring that every data point generated is scientifically robust and submission-ready.
Unlike traditional CDMOs, contract testing labs, or regulatory consulting firms, CMC Pharma is a single, full-service development partner. This one-partner model eliminates hand-offs, reduces misalignment, and avoids costly delays associated with multiple vendors or external consultants.
Our services are designed to help you move faster and more efficiently from early discovery through clinical development and commercialization, with built-in regulatory guidance.
Pharmaceutical formulation development is the process of designing, creating, and verifying that the selected drug product is safe, effective, and consistently delivers a desired therapeutic effect. It involves the selection of appropriate ingredients (excipients), dosage form, manufacturing process, and packaging to optimize the drug’s properties and ensure its stability and shelf life. The team at CMC Pharmaceuticals has decades of experience designing and developing drug products while utilizing a variety of formulation approaches.
The formulation development process involves several stages, including pre-formulation studies, formulation design and evaluation, manufacturing scale-up and process development, analytical development and characterization, and stability and shelf life determinations. Each stage is crucial for the successful development a drug product.
CMC Pharma’s model delivers the expertise needed throughout the entire drug development process and serves as a fully integrated contract lab for pharmaceutical formulation development. Learn more below:
Pre-formulation studies are the initial steps in the pharmaceutical formulation development process. These studies evaluate the chemical properties of the drug substance, such as solubility, stability, and compatibility, with other excipients. The results of pre-formulation studies help in selecting the appropriate dosage from and excipients for the formulation.
Formulation design is the process of selecting the appropriate dosage form and excipients for the drug substance. The dosage form can be a solid, liquid, semisolid, or dispersion depending on the drug’s physical and chemical properties and target patient population. The excipients are selected based on the compatibility with the drug substance, their function in the formulation, and their safety profile. Evaluation of the drug product with analytical, in vitro, and in vivo studies ensures that it meets FDA and ICH requirements and the desired target product profile.
CMC Pharma excel in the most common routes of administrations (tablets, capsules, injectables) and also has specific expertise with innovative and complex drug delivery systems such as polymeric controlled release, in situ forming gels, suspensions, and more.
Process development is the optimization of the manufacturing process to ensure consistent quality, yield, and purity of the drug product. The manufacturing process is designing to ensure that the drug product meets the required specifications and is produced in compliance with regulatory requirements. The appropriate scale of the manufacturing process needs to be consistent with the needs of pre-clinical, clinical, and commercial requirements for the drug product.
Analytical methods must be developed to ensure that the drug product meets the identity, purity, and potency specifications and requirements. The workhorse of a pharmaceutical drug product development lab is Ulta and High Performance Liquid Chromatography (U/HPLC) instruments that are utilized to measure the purity and potency of a drug product. However, additional analytical methods are also employed to quantify residual water, critical excipient levels and other impurities, drug dissolution and release, pH, osmolarity, appearance, particle size, and other critical quality attributes.
Stability testing is a critical aspect of the formulation development process. It ensures that the drug product maintains its quality and efficacy over time. Pharmaceutical stability testing involves exposing and storing the drug product to various environmental conditions, such as temperature, humidity, light, and monitoring its physical and chemical properties over time. The stability data is then used to determine the appropriate storage condition and the shelf-life of the drug product. CMC Pharma executes both routine and custom-designed stability studies. Our formulation lab enables stability studies to be performed compliant with cGMPs, FDA regulations, and ICH guidance as needed for regulatory submissions.
Pharmaceutical formulations must comply with regulatory requirements to ensure patient safety and efficacy. Regulatory authorities, such as the US Food and Drug Administration (FDA), require that drug products meet certain quality, safety, and efficacy standards before they can be approved for marketing.
Partner with CMC Pharma for development services that are fast, flexible, and fully integrated. We combine scientific expertise, regulatory foresight, and operational excellence to advance your small molecule and complex drug programs efficiently and successfully.
Whether you need to develop robust analytical methods or require routine testing, Contact CMC Pharma to learn how we can help you advance your development program.
Send us a message or give us a call at 440-485-1734
