Seamless Transition from Clinical to Commercial Production 

At MedPharm, our Scale-Up Manufacturing services ensure a smooth transition of topical and transdermal drug formulations from small-scale clinical batches to full-scale commercial production, all while maintaining product quality, consistency, and regulatory compliance. Our expertise in process optimization, batch reproducibility, and technology transfer allows pharmaceutical companies to efficiently increase production capacity without compromising formulation integrity or stability.   

With a GMP-certified manufacturing environment, advanced process engineering, and regulatory-driven scale-up strategies, MedPharm accelerates time to market while minimizing the risks associated with scaling production.    

Key Components of Scale-Up Manufacturing  

Process Optimization for Efficient Scale-Up  

✔ Identification of critical process parameters (CPPs) to ensure reproducibility  

✔ Optimization of mixing, homogenization, and emulsification techniques  

✔ Implementation of Quality by Design (QbD) principles to enhance efficiency  

✔ Risk mitigation strategies to address batch-to-batch variability  

GMP-Standard Scale-Up for Late-Stage & Commercial Production  

✔ Seamless transition from small-scale to large-scale batch manufacturing  

✔ Increased batch sizes while maintaining regulatory and quality standards  

✔ GMP-certified facilities ensuring compliance with FDA, EMA, and ICH regulations  

✔ Full traceability and batch documentation for regulatory filings    

Technology Transfer & Commercial Readiness  

✔ Transfer of validated processes to commercial manufacturing facilities  

✔ Reproducibility assessments to ensure process integrity across scales  

✔ Comprehensive documentation for seamless knowledge transfer  

✔ Collaboration with contract manufacturers for large-scale production   

Regulatory Support for IND, NDA & ANDA Filings  

✔ Preparation of CMC (Chemistry, Manufacturing & Controls) documentation  

✔ Scale-up validation studies to support regulatory submissions  

✔ Analytical and stability testing to ensure product quality  

✔ Compliance with global regulatory expectations for commercial production     

Ensure Manufacturing Success with MedPharm’s Scale-Up Expertise 

MedPharm develops processes based on scientific guidance, implements regulatory-aligned scale-up strategies, and utilizes GMP-certified manufacturing to prepare topical and transdermal drug products for large-scale production, regulatory approval, and commercial success.