Reliable, GMP-Compliant Drug Supply for Every Phase

MedPharm’s Clinical Trial Manufacturing services deliver high-quality, GMP-compliant drug products to support Phase I, II, and III clinical trials. With expertise in topical and transdermal formulations, we ensure that investigational drug products are produced with precision, consistency, and full regulatory compliance to meet clinical development needs.   

From small-scale pilot batches to more extensive Phase III clinical trial production, our team guarantees that each batch is manufactured, tested, and packaged to the highest quality standards. This gives pharmaceutical companies the critical supply chain support for clinical success.  

Key Components of Clinical Trial Manufacturing   

GMP-Compliant Clinical Batch Manufacturing  

• Small-scale, pilot-scale, and Phase I, II, and III clinical trial batch production  

• GMP-certified facilities ensuring regulatory compliance  

• Strict in-process controls (IPCs) to maintain batch-to-batch consistency  

• Flexible batch sizes tailored to clinical trial requirements 

Process Optimization & Scale-Up Support  

• Evaluation of formulation performance for clinical readiness  

• Optimization of compounding, mixing, and emulsification processes  

• Identification of critical process parameters (CPPs) for reproducibility  

• Seamless transition from clinical trial supply to commercial-scale production 

Clinical Packaging, Labeling & Supply Chain Management  

• Tailored primary and secondary packaging solutions for clinical needs  

• Labeling that complies with global regulatory requirements  

• Cold chain and controlled-environment storage options  

• Efficient distribution strategies to trial sites worldwide  

Regulatory Support for IND, NDA, & ANDA Submissions  

• CMC (Chemistry, Manufacturing & Controls) documentation for clinical submissions  

• Stability studies supporting clinical development and long-term viability  

• Analytical method validation to ensure regulatory compliance  

• Adherence to FDA, EMA, ICH, and global clinical trial regulations  

Ensure Clinical Trial Success with MedPharm’s Manufacturing Expertise

MedPharm ensures that your clinical trial drug supply is produced with precision, reliability, and regulatory compliance through scientifically driven process development, GMP-compliant production, and seamless supply chain management.