Why use the service of an expert

CMC (chemistry, manufacturing and control) is an essential part of the marketing authorization process for a new IMP (investigational medicinal product). CMC development is a continuous process of knowledge and understanding of the product and drug substance throughout the clinical phases to ensure the safety and consistency of the product. The requirements at different phases of clinical development are different and increase as the clinical phase progresses.

To meet the demands of regulatory agencies and ensure that your program is progressing well, you need expert support and guidance during development, which is the best way to reduce time and cost and to conduct the development process as effectively as possible.

At ThenSoar CMC, we support you by providing scientific and regulatory expertise during CMC development. We know how to anticipate and overcome potential difficulties during product development, especially those based on encapsulated nucleic acids that form particulate nanocomplexes.

We realize that innovation is often driven by small and medium-sized companies, so we provide services tailored to your budget and timelines with fast reactivity and flexibility as a high-quality extension of your team.

Our network of contract manufacturing and research organizations (CMOs and CROs) plus an extensive network of experts allows us to identify the most appropriate service providers for your compound and pharmaceutical form and ensure optimal performance within your time and budget parameters.

At ThenSoar CMC Consulting, we provide you with formulation and process design assistance, manage suppliers (CMO and CRO), design/review analytical and production protocols, identify the best product characterization strategy to ensure compliance with ICH guidelines and scale-up product manufacturing to GMP quality.

Experienced management of these activities ensures the quality of the materials being produced and the reliability of the clinical supply chain as the project progresses.

Why us

Drug development requires innovation, creativity and field experience to obtain a successful path to approval. A successful program can provide a high-value opportunity for a drug development company.

ThenSoar's CMC consulting serves the needs of small emerging biotechs, most of which have a single product-based development pipeline, and those mid- to large-sized companies with early-stage encapsulated nucleic acid-based products. Whether it is designing CMC strategy, directing CMC operations or developing CMC presentation content that represents the best interests of the company. We focus on critical and regulatory CMC issues and build programs that enhance development.

We are ideally positioned to help develop and guide a successful and efficient drug development program and create a high-value opportunity for your company while avoiding issues such as clinical suspension or agency concerns in your company's CMC area. In addition, we provide our clients with development strategies that drive the overall development process to meet milestones in a time and cost-effective manner.

From sourcing APIs and formulations, to manufacturing, scale-up and packaging, we provide high-value strategic guidance and CMC development services.

Let us help you transform your discovery into a pharmaceutical product with the best chance of approval and future profitability.