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Small Molecules
Our end-to-end solutions ensure global success
Whether you are developing novel small molecules or repurposing existing ones, we help bring innovative therapies to global markets faster and more effectively.
Interdisciplinary Expertise Applied to All Stages of Development
We offer comprehensive, tailored solutions across the entire lifecycle, including market access, regulatory strategy & operation, clinical trials management, and CMC optimization.
Global Reach with Local Focus
Our global presence and localized expertise help you navigate regional regulatory requirements and market landscapes, ensuring your small molecule therapy — whether novel or repurposed — achieves rapid global market access.
FAQs
What are the CMC (Chemistry, Manufacturing, and Controls) considerations for small molecule development and drug repurposing?
For new small molecules, CMC challenges include optimizing the synthesis of the Active Pharmaceutical Ingredient (API), ensuring product stability, and scaling up manufacturing processes for clinical and commercial use.
In drug repurposing, while the API may already be established, CMC challenges can arise if new formulations or delivery methods are needed for the repurposed indication. Both require strict quality control and regulatory compliance.
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How can clinical trials be optimized for both new small molecules and repurposed drugs?
For new small molecules, clinical trials need to be carefully designed to determine safe dosages, monitor adverse effects, and demonstrate efficacy.
For repurposed drugs, clinical trials can often focus on proving efficacy for the new indication, with existing safety data allowing for faster trial phases. Utilizing adaptive trial designs and leveraging existing patient populations can also expedite the process.
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Related Glossary
Chemistry, Manufacturing, and Control (CMC)
Quality-by-Design(QbD)
New Drug Application (NDA)
LCM (Life Cycle Management)
Investigator’s Brochure
Questions? Get the answers from our expert team
No two product development paths are the same. Talk to our experts about your development challenges and we will provide you actionable recommendations.