Pharmaceutical Formulation Development Services
Capabilities in Formulation Development
The pharmaceutical formulation and process development services at CMC Pharma help product developers, manufacturers, and entrepreneurs turn innovative ideas into approved products. We provide contract formulation development solutions on a wide range of active pharmaceutical ingredients (API), including for drug products that are challenging to stabilize or solubilize.
CMC Pharma specializes in the most common routes of administration with traditional formulations including oral solid dosage forms and liquid injectables, and more innovative and complex drug delivery systems (polymeric controlled release, in situ forming gels, suspensions, etc.) to overcome your development challenges and maximize the safety and efficacy of your drug product. Oral liquid formulation development capabilities include suspensions, solutions, and controlled-release liquid systems. Our capabilities include the identification and preparation of drug product prototypes in our pilot plant for in vitro and in vivo studies.
We also provide expert laboratory services to remediate existing drug products to meet current FDA regulations. We focus on understanding the characteristics and the requirements of your pharmaceutical product, FDA and worldwide regulations, and applying scientific rigor and innovation to bring your product to market.
Our laboratory and pilot plant support every stage of drug formulation development, from feasibility through scale-up. We design stage-appropriate studies to meet both scientific and regulatory expectations, always keeping long-term commercialization in mind.
Pharmaceutical Pre-Formulation & Formulation Services Include:
Compatibility Evaluation
Our capabilities include evaluating the stability of a compound in long-term storage, accelerated, compatibility, and forced degradation studies. Evaluating the effect of pH, residual moisture, and understanding the degradation mechanism (e.g. hydrolysis, oxidation, impact of light, temperature, etc.) are critical when designing the appropriate formulation and analytical methods.
Poorly Soluble Drugs
Active pharmaceutical ingredients (APIs) with low solubility can provide significant development hurdles with respect to slow dissolution, low and variable bioavailability and absorption, inability to deliver high toxicological doses, and difficulty in developing liquid formulations. We experimentally analyze a compound’s solubility in a number of pharmaceutically acceptable solvents to overcome these challenges through evaluation of a number of systems using solvents, co-solvents, surfactants, alternative salt or solid-state forms, pH adjustments and buffers, and drug complexes to improve solubility.
Lead Optimization & Candidate Selection
We are specialists in providing pre-formulation guidance and evaluation to optimize compound selection. Our scientists understand the life cycle of a pharmaceutical product and can help identify the optimal compound to move forward into development. Our prototype preparation services (RAMP) also provides an invaluable advantage to drug developers to demonstrate proof-of-concept and feasibility.
Dosage Form Selection
Our experienced team helps to determine if your drug candidate is appropriate for oral solid dosage forms, injectable, inhaled, controlled release, or other novel dosage forms. We evaluate the physicochemical data in collaboration with pharmacologists and biologists to identify the optimal dosage form for toxicology evaluation, clinical studies, and beyond. RAMP enables developers fast and flexible production of prototypes.
Excipient Compatibility Studies
During early formulation development, we execute excipient compatibility studies for selection of the components in an acceptable formulation (e.g. stabilizers, binders/disintegrants/lubricants, solubilizers, preservatives, buffers, tonicifiers, etc.). Appropriate and compatible excipients allowing optimal design of a comprehensive formulation development program to meet all FDA and ICH requirements.
Comprehensive Formulation & Analytical Development
Our extensive experience in designing and executing appropriate formulation and analytical development studies for early phase products creates a strategic path to move your product in to the clinic with the ultimate goal of product approval. Our integrated model provides you with a flexible and responsive drug development partner to expedite your programs success.
Our Pharmaceutical Formulation Expertise Covers:
- Traditional dosage forms: tablets, capsules, injectables
- Complex formulations: long-acting injectables, controlled release, suspensions
- Reformulation strategies: to improve shelf life, stability, or solubility
- Combination products: two or more APIs
- Specialized approaches: non-aqueous vehicles, highly potent APIs (cytotoxics, hormones, beta-lactams)
Understanding the Drug Development Process and The Importance of Formulation Development
What is Formulation Development?
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.
Drug formulation development 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 drug formulation development.
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 form 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 excels in the most common routes of administrations, including oral solid dosage forms (tablets, capsules), injectables, oral liquids, 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 designed 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.
Our pharmaceutical analytical chemistry services ensure that the drug product meets the identity, purity, and potency specifications and requirements. The workhorse of a pharmaceutical drug product development lab is Ultra 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.
Process Development Capabilities
Our team develops robust, reproducible processes designed for seamless scale-up and regulatory compliance. We optimize critical process parameters, define control strategies, and support technology transfer to your selected CMO. By integrating process development early, we reduce risk and ensure your formulation can be manufactured consistently and cost-effectively.
Our GMP-compliant formulation development lab handles oral solid dosage forms, liquid, and injectable programs. By integrating formulation and process development, we ensure your product is designed not just for clinical success, but also for seamless manufacturing and commercialization.
The Importance of Formulation and Process Development
Formulation and process development are the foundation of any successful drug product. The right formulation ensures drug stability, solubility, and patient safety, while robust process development ensures that the product can be manufactured consistently, cost-effectively, and in compliance with cGMP regulations.
CMC Pharma specializes in both, offering you comprehensive lab services that de-risk your pipeline and streamline the path from discovery to market.
End-to-End Contract Formulation Development Services
CMC Pharma is more than a traditional CDMO or consulting firm. We are a full-service drug development partner, providing a seamless, integrated pathway from early discovery through commercialization. Unlike providers limited to a single technology or dosage form, we deliver flexible, stage-appropriate solutions that accelerate development while reducing risk.
Our development laboratory advances pharmaceutical formulation development services and process development with scientific rigor, while our manufacturing enablement services—including prototype preparation (RAMP), scale-up and tech transfer, CMO selection, and GMP manufacturing oversight—ensure your drug products are optimized not only for clinical success, but also for efficient, compliant, and scalable manufacturing.
By embedding regulatory guidance throughout development, we help clients de-risk their pipeline, streamline program execution, and accelerate timelines. CMC Pharma acts as a true extension of your team, uniting science, operations, and compliance into a fully integrated drug development solution that delivers predictable, high-quality outcomes and faster access to innovative therapies.
Explore Our Drug Development Services:
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CMC Pharma is a preferred contract formulation development lab and routinely assists companies at the various stages of drug product development.
Send us a message or give us a call at 440-485-1734