CMC Drug Development Consulting

In drug development, Critical Quality Attributes (CQAs) must be identified and controlled to warrant the safety, efficacy, and quality of the final product. CQAs are the physical, chemical, biological, or microbiological properties that must be within specified limits to meet the product’s intended performance.

We work with our clients to define and monitor CQAs throughout the drug development life cycle. By understanding these early on, we help you mitigate risks and address issues before they become problems to get approval smoothly.

A successful drug product is built on the seamless integration of CMC drug development work with each stage of the clinical trial process. We know that aligning CMC with clinical trial milestones is key to maintaining the quality and safety of the drug product throughout its life cycle.

From Phase I to Phase III trials, we make sure that your drug product meets regulatory standards. In the early phases, we develop scalable manufacturing processes, select the right raw materials, and establish robust analytical methods. These foundation elements are critical to the product being tested in clinical trials, which are of the highest quality and directly impact clinical outcomes.

As clinical development progresses, CMC is critical to product consistency across batches. Manufacturing processes must scale up to meet increasing demand while still meeting strict regulatory requirements. We make sure that any scale-up or process changes during clinical trials do not impact the quality or safety of the drug. We also provide full documentation and regulatory submissions so all CMC activities are compliant with FDA and EMA regulations as your product moves through Phase II and III trials.

Our team can develop and validate analytical methods to your product’s specific requirements. Whether testing for potency, purity, or stability, our scientifically robust approaches will corroborate your drug product meets regulatory standards and is of high quality.

• Potency Testing: We develop methods to measure the active ingredient in your drug for a consistent therapeutic effect.
• Purity Testing: Impurities can have a big impact on product safety. We can help you develop methods to detect and quantify impurities that could affect product quality.
• Stability Studies: Stability testing confirms your drug remains of the same quality and effectiveness over time. We can support you with both short-term and long-term stability studies for product viability throughout its life cycle.

From lab scale to full commercial production, the journey is full of complexities. We create formulations that are effective and manufacturable at scale, addressing common formulation and manufacturing challenges such as solubility and stability. Our services cover every stage from formulation development to process scale-up and technology transfer to confirm a smooth transition from small batch to large batch manufacturing.

Our approach to manufacturing process development is based on scientific precision and flexibility. We work with you to design processes that are robust, reproducible, and compliant with regulations. This includes selecting the right equipment for your product, optimizing formulations, and creating processes that are scalable for today’s and tomorrow’s market demands.

• Formulation Development: We create formulations that are effective and manufacturable at scale. From solving solubility issues to guaranteeing product stability, our team navigates the formulation nuances to get the best results.
• Process Scale-Up: Going from lab scale to commercial scale production can be tricky. Pharmaceutical companies develop strategies for smooth scale-up that maintain product quality and consistency.
• Technology Transfer: Our experts facilitate technology transfer between development stages to make certain knowledge and processes are communicated and implemented across sites.
• Equipment Selection: Choosing the right equipment for manufacturing is key to product success. We guide you in selecting and validating equipment that can support flexible production and meet varying output demands without compromising quality.