At Pharmaceutical Innovation Services S.L., we understand that CMC (Chemistry, Manufacturing, and Controls) is a critical component in the pharmaceutical development process. The seamless technology transfer and scientific knowledge from development to commercial production are essential to ensure a successful industrial implementation, an efficient supply chain, and consistent commercial production. Our expert services are designed to support your company in achieving these goals, from the initial scale-up to ongoing lifecycle management.

Support for Technology Transfer and Manufacturing

The process of technology transfer involves transferring the manufacturing process, analytical methods, and all relevant scientific knowledge from the development environment to the production site. This step is crucial for ensuring that your product is manufactured efficiently, consistently, and to the highest quality standards. At Pharmaceutical Innovation Services S.L., we offer advice and support throughout this process, ensuring that the transfer is successful and that the manufacturing process is fully optimized for commercial production.

Key Services in CMC and Technology Transfer

Our CMC and technology transfer services include a wide range of offerings designed to meet the specific needs of your project:

• Active Ingredient Permitted Daily Exposure (PDE) Report: We provide detailed writing and review services for PDE reports, ensuring that all safety thresholds are accurately calculated and documented for regulatory compliance.
• Nitrosamines Risk Assessment Report: Nitrosamines are a critical concern in pharmaceutical manufacturing. We conduct thorough risk assessments to identify and mitigate potential nitrosamine contamination, ensuring the safety and compliance of your products.
• Risk Assessment for Cross-Contamination Prevention: Cross-contamination poses significant risks in pharmaceutical manufacturing. We perform comprehensive risk assessments to develop strategies that prevent cross-contamination, safeguarding product integrity and patient safety.

Optimizing Manufacturing Processes and Supply Chain

In addition to our core CMC services, Pharmaceutical Innovation Services S.L. offers specialized support to optimize your manufacturing processes and supply chain:

• CMO Network Optimization: We evaluate and optimize your Contract Manufacturing Organization (CMO) network to ensure that you are working with the best partners, maximizing efficiency and reducing costs.
• Supply Chain Analysis and Simplification: An efficient supply chain is vital for maintaining production schedules and minimizing costs. We analyze your supply chain to identify areas for simplification, ensuring a streamlined and cost-effective process.
• Inventory Management and Production Planning Evaluation: Proper inventory management and production planning are crucial for avoiding shortages and overproduction. We provide expert evaluations to help you manage inventory effectively and plan production to meet market demands efficiently.
• Troubleshooting for Mature Products: Over time, mature products can face issues with robustness and cost efficiency. We offer troubleshooting services to identify and resolve these issues, improving product performance and reducing costs.

Quality Assurance and Lifecycle Management

Quality assurance (QA) is a cornerstone of successful pharmaceutical manufacturing. Our services include QA assistance during the manufacturing process, ensuring that all operations meet the highest quality standards.

Additionally, we offer lifecycle management services to support the ongoing success of your product:Additionally, we offer lifecycle management services to support the ongoing success of your product:

• Project Management for API Source Changes: Whether you’re adding a new API source, changing manufacturing sites, or updating excipients and equipment, we provide expert project management to guide you through these changes smoothly.
• Manufacturing Process Improvements: Continuous improvement is key to maintaining competitive advantage. We help you identify opportunities to enhance your manufacturing processes, improving efficiency and product quality.

Why trust Pharmaceutical Innovation Services S.L. to optimize your manufacturing processes and technology transfers?

At Pharmaceutical Innovation Services S.L., we are dedicated to providing CMC and technology transfer services that ensure your pharmaceutical products are manufactured efficiently, safely, and cost-effectively. Our expertise in these areas allows us to support your company at every stage of the manufacturing process, from initial scale-up to full commercial production, and throughout the product lifecycle. Let us help you achieve excellence in pharmaceutical manufacturing and technology transfer.