Process Development
Transforming Innovation into Scalable, Commercially Viable Processes
At MedPharm, our Process Development, Quality by Design (QbD), and Scale-Up services offer pharmaceutical companies a structured, data-driven approach to optimizing drug manufacturing processes. We ensure regulatory compliance and facilitate seamless transitions from small-scale development to commercial production.
By implementing QbD principles, process validation strategies, and advanced scale-up methodologies, we guarantee that topical and transdermal drug products achieve batch-to-batch consistency, stability, and readiness for regulatory approval.
Ensure Scalable, Regulatory-Compliant Drug Production with MedPharm’s Expertise
With scientifically guided process development, QbD implementation, and seamless scale-up strategies, MedPharm ensures that your topical and transdermal drug formulations transition from early-stage development to full-scale manufacturing.
Explore Our Process Development Solutions:
Characterization & Optimization
Turning Scientific Insights into Scalable, High-Performance Drug Products At MedPharm, Characterization & Optimization is the critical phase where formulation science meets process precision. This step enables our scientists to refine every aspect of your drug product—transforming early-stage concepts into scalable, stable, and therapeutically effective solutions.
Process Development – Optimizing Efficiency & Consistency
Identification of critical process parameters (CPPs) and quality attributes Optimization of mixing, homogenization, emulsification, and drug dispersion techniques Validation of excipient interactions for stability and efficacy Implementation of in-process controls (IPCs) for real-time product quality monitoring
Quality by Design (QbD) – Enhancing Product Reliability & Compliance
Risk-based approach to process and formulation design ICH Q8, Q9, and Q10-compliant methodology for process understanding Design of Experiments (DoE) to identify optimal process conditions Regulatory-aligned process validation to ensure long-term consistency
Regulatory Compliance & Manufacturing Readiness
CMC (Chemistry, Manufacturing & Controls) documentation for IND, NDA, and ANDA filings GMP-compliant process development ensuring adherence to global regulatory standards Comprehensive process validation reports for regulatory submissions Risk management strategies to address scale-up deviations and compliance gaps
Scale-Up – Seamless Transition from Lab-Scale to Commercial Manufacturing
Pilot-scale and clinical-scale batch production for process refinement Identification of scale-up challenges to ensure seamless technology transfer Batch-to-batch reproducibility assessments for regulatory filings Equipment and facility compatibility assessments for commercial production
Scale-Up & Technology Transfer
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.
