Bridging Innovation and Manufacturing with Confidence 

In pharmaceutical development, exceptional formulations require more than just scientific brilliance—they need a well-structured and strategic path to commercial scale. At MedPharm, our Scale-Up & Technology Transfer services are specifically designed to convert your lab-scale innovations into full-scale production efficiently, accurately, and with regulatory assurance.  

As a specialized Contract Development and Manufacturing Organization (CDMO) focused on topical and transdermal drug products, we understand the complexities involved in transitioning from the bench to batch production. Our integrated teams and purpose-built infrastructure guarantee that your product performs consistently, whether it is manufactured at our facility or yours.  

A Critical Link in the Development Chain 

Successful scale-up and transfer are not left to chance; they are meticulously planned. MedPharm approaches this phase with thorough planning, deep technical insight, and clear communication across all disciplines. 

Our work ensures: 

• Seamless knowledge transfer from development to manufacturing 

• Scalable processes that maintain product integrity and quality 

• GMP-compliant documentation ready for regulatory inspection 

• Alignment among formulation, analytical, and production teams 

• Minimized risk during clinical and commercial manufacturing

Explore Our Expertise 

Our scale-up and transfer programs are customized to meet your product’s specific needs, timelines, and long-term strategies. Learn more about our specialized services:  

Technology Transfer 

Ensure a seamless transfer of process and analytical knowledge—whether internally or to external partners—through detailed protocols, training, and cross-site alignment.  

Key Components of Technology Transfer 

• Comprehensive transfer of formulation knowledge and process parameters 

• Detailed batch records, standard operating procedures (SOPs), and production guides 

• Identification of critical process parameters (CPPs) and quality attributes 

• Training programs to ensure knowledge continuity at the receiving site

Manufacturing Site Readiness & Scale-Up Feasibility 

• Evaluation of facility capabilities and equipment compatibility 

• Gap analysis to ensure the seamless transfer of methods and processes 

• Optimization of mixing, homogenization, and emulsification techniques 

• Assessment of production scalability for pilot and commercial batches

Process Validation & Quality Assurance

• Process validation studies to confirm reproducibility across different sites 

• Batch-to-batch consistency studies for regulatory approval 

• Implementation of in-process controls (IPCs) for real-time monitoring 

• Adherence to Quality by Design (QbD) principles for risk mitigation

Regulatory Compliance & CMC Support 

• Alignment with global regulatory agencies (FDA, EMA, ICH) for approval readiness 

• CMC (Chemistry, Manufacturing & Controls) documentation for NDA and ANDA filings 

• Audit support to ensure regulatory compliance at new manufacturing sites 

• Comprehensive risk assessment and mitigation strategies

Scale-Up Process 

Transition from lab-scale to pilot-scale and finally to commercial-scale production with processes optimized for consistency, yield, and regulatory readiness.  

What We Do in the Scale-Up Process:

Process Characterization 

We evaluate key process parameters (such as mixing speeds, temperatures, and order of addition) to understand how formulations behave at different batch sizes. This data-driven approach establishes a foundation for reliable scale-up.  

Pilot-Scale Trials 

Intermediate batch sizes are produced using representative equipment to assess manufacturability, ensure product integrity, and identify potential technical challenges before full-scale production.  

Process Optimization & QbD 

We utilize Design of Experiments (DoE) and statistical modeling to optimize parameters that impact performance, stability, and yield, ensuring robust and reproducible results at a commercial scale.  

Tech Transfer & Equipment Mapping 

Our experts facilitate the seamless transfer of processes to internal or external GMP manufacturing sites, aligning process requirements with available equipment and capabilities.  

GMP Batch Production 

Once the process is defined and validated, we support the production of clinical trial materials, registration batches (PPQ), and eventually full commercial lots, all under GMP-compliant conditions.  

Why Choose MedPharm?

• Decades of experience in scaling complex semisolid and liquid formulations 

• Proven success in transferring products across multiple global sites 

• In-house GMP manufacturing with flexible production suites 

• Integrated quality assurance, regulatory, and scientific support 

• Collaborative project teams focused on transparency and precision

Where Expertise Meets Execution  

Your product’s future depends on its ability to scale, and MedPharm is your trusted partner at every step. From early planning to successful commercial transfer, we ensure that quality, consistency, and compliance are never compromised.  

Let’s move forward—together.