Key CDMO Capabilities

Our extensive CDMO capabilities span a wide range of services, offering a complete platform to meet all development and manufacturing needs:

1. Drug Development

Ewing Pharma provides comprehensive drug development services, from preclinical research to clinical trial material supply. Our R&D team has expertise in API development, formulation, and process optimization, ensuring that our clients can progress seamlessly through the drug development pipeline. Our services include:

• API Development: Expertise in developing high-quality Active Pharmaceutical Ingredients with consistent performance.
• Formulation Development: Tailored solutions for creating robust and scalable drug formulations.
• Analytical Development: Comprehensive testing and validation services to support regulatory submissions.

2. Process Development & Optimization

Our process development services focus on optimizing manufacturing processes to improve efficiency, reduce costs, and ensure quality. By leveraging advanced technologies and innovative approaches, we refine production methods to ensure that clients receive optimal results at every stage. Our process development expertise includes:

• Scale-Up Services: Transition from lab-scale production to commercial manufacturing.
• Process Optimization: Streamlining production for maximum yield and efficiency.
• Technology Transfer: Seamless transfer of technology from clients to our manufacturing facilities, ensuring smooth execution.

3. Manufacturing Services

With state-of-the-art facilities and stringent quality control measures, Ewing Pharma offers contract manufacturing services for both small and large-scale projects. Our manufacturing services include:

• API Manufacturing: High-quality API production under strict GMP standards.
• Intermediates Manufacturing: Scalable solutions for producing pharmaceutical intermediates.
• Formulated Products: Expertise in manufacturing oral solids, liquids, and complex formulations.

Our manufacturing capabilities are designed to meet the highest regulatory standards, ensuring that our clients’ products are produced safely, efficiently, and with full compliance.

4. Supply Chain Management

Effective supply chain management is critical to ensuring timely delivery of pharmaceutical products. Ewing Pharma provides end-to-end supply chain services, managing everything from sourcing raw materials to distributing finished products. Our robust supply chain solutions ensure smooth logistics and reliable delivery, enabling clients to meet market demands without delay.

5. Regulatory Support

Navigating the complex regulatory landscape is essential in bringing pharmaceutical products to market. Ewing Pharma’s regulatory support services ensure that clients are fully compliant with global standards and guidelines, helping to expedite approvals and minimize risks. Our regulatory expertise covers:

• Dossier Preparation: Full support in compiling regulatory dossiers for product registration.
• Compliance Audits: Ensuring all processes meet stringent regulatory requirements.
• Global Regulatory Guidance: Assistance with international regulatory submissions and approvals.