Chemistry, Manufacturing & Controls (CMC)
Chemistry, Manufacturing & Controls (CMC)
Consulting and Management
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Effectively overcome regulatory, scientific, and technical compliance challenges in API and pharmaceutical product development with expert guidance
Strategic and Operational
CMC Consulting
ThenSoar CMC Consulting supports startups, small biotech companies, and biopharmaceutical companies to optimize the development process and ensure regulatory compliance in the chemistry, manufacturing, and control (CMC) of pharmaceutical substances and products, with a special focus on nucleic acid-based encapsulated products in early development.
Why work with a CMC Consultant
Ensuring compliance with Chemistry, Manufacturing and Controls (CMC) practices is essential for companies throughout the life cycle of the investigational product. Failure to comply with current regulatory requirements carries significant consequences, such as possible withdrawal of marketing authorization, fines and suspension of distribution of the medicine. Regular updates to CMC strategy are imperative due to the changing nature of regulatory standards. Collaborating with an experienced global partner like ThenSoar CMC Consulting on regulatory strategy and CMC development becomes essential for thorough analysis and documentation of manufacturing processes, ensuring product safety, effectiveness, and consistency.
Minimizing Risks
We excel at defining strategies to "eliminate risks" in the development process of pharmaceutical substances and products. This concerns formulation development, manufacturing setup and scale-up, analysis of release and stability data, the establishment of specifications, the design of container closure systems, and standards for both non-GMP and GMP manufacturing.
We Focus on:
Meet Regulatories Agencies Expectations
ThenSoar CMC Consulting ensures CMC compliance so that your projects meet the requirements and expectations of regulatory agencies. We have extensive experience in pharmaceutical products based on nucleic acids encapsulated in sterile injectable preparations, chemicals and oncology products, all put at the service of the client. ThenSoar CMC Consulting's team can help you reduce risk and become more time and cost-efficient during pharmaceutical product development.
Tailored Solutions for Client
We work to support internal teams with external expertise to assist in strategic positioning against agencies, continuously monitoring operational activities and providing a variety of solutions that are tailored to each client's needs.
Benefits
Our commitment is to help you develop the best pharmaceutical products.
We are experts in development of pharmaceutical products based on encapsulated nucleic acids and nanoparticles with a decade of experience working in the biotech industry. The CMC's early development expertise enables us to help our clients shorten timelines and mitigate risks during pharmaceutical development.
We have an unparalleled commitment to your project.
ThenSoar CMC Consulting
ADDRESS:
6 Liberty Square # 2790
Boston, MA 02109
PHONE NUMBER
+1 (617)-420-4328
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