Explore Our Clinical Supply Capabilities 

Select a service to learn more: 

🧪 Clinical Trial Manufacturing 

GMP-compliant manufacturing of investigational drug products (IMPs) for Phase I–III trials. Our scalable, repeatable processes are designed for consistency, compliance, and audit readiness. 

📈 Scale-Up Manufacturing 

We bridge lab-scale formulations and clinical-scale production using proven strategies for process adaptation, equipment alignment, and formulation robustness. 

📦 Registration Batches (PPQ & Validation Batches) 

We support pivotal registration batches, including Process Performance Qualification (PPQ) and validation studies, designed to meet regulatory requirements and ensure commercial readiness. 

✅ Quality & Regulatory-Focused Manufacturing 

Our manufacturing process emphasizes precision and compliance, integrated with QA oversight and global regulatory alignment to ensure that investigational drug products are delivered without compromise. 

Why MedPharm? 

• Specialist in Topical and Transdermal Clinical Supply 

• We have decades of experience with dermatological and semisolid dosage forms. 

• End-to-End Integration 

We provide a seamless link between formulation, manufacturing, testing, and packaging. 

• Regulatory Confidence 

Our GMP manufacturing aligns with FDA, EMA, MHRA, and global trial expectations. 

• Flexible Batch Sizes & Rapid Turnaround 

Our services are designed to support early feasibility through late-stage development. 

Clinical Supply You Can Count On 

Your clinical trial depends on the availability, consistency, and quality of your investigational product. MedPharm delivers—with science, structure, and speed.  

Let’s build your clinical supply strategy—dose by dose. 

Clinical Trial Manufacturing

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 

🔹 [Learn More About GMP & Quality-Controlled Manufacturing →] 

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 

🔹 [Learn More About Process Development & Scale-Up →] 

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 

🔹 [Learn More About Clinical Packaging & Logistics →] 

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 

🔹 [Learn More About Regulatory & Compliance Expertise →] 

Why Choose MedPharm for Clinical Trial Manufacturing? 

• Industry-leading expertise in topical and transdermal clinical manufacturing 

• Regulatory-compliant GMP production for clinical trial supply 

• Comprehensive stability and analytical testing for IND, NDA, and ANDA filings 

• Seamless scale-up from clinical trial batches to commercial manufacturing 

• Flexible packaging and labeling solutions for global clinical supply 

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. 

Contact us today to learn how our Clinical Trial Manufacturing services can support your clinical development and regulatory approval goals! 

Scale-Up Manufacturing

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 

🔹 [Learn More About Process Development & Optimization →] 

 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 

🔹 [Learn More About GMP Manufacturing Capabilities →] 

 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 

🔹 [Learn More About Technology Transfer →] 

 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 

🔹 [Learn More About Regulatory & Compliance Expertise →] 

 Why Choose MedPharm for Scale-Up Manufacturing? 

✅ Industry-leading expertise in scaling topical and transdermal formulations 

✅ Regulatory-compliant scale-up for IND, NDA, and ANDA filings 

✅ GMP-certified facilities supporting clinical and commercial manufacturing 

✅ Seamless integration with process development and technology transfer 

✅ Comprehensive analytical and quality control for large-scale 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. 

Registration Batches (PPQ & Validation Batches)

Ensuring Regulatory Compliance for Market Approval 

As drug products move toward commercialization, Process Performance Qualification (PPQ) and validation batches are essential for obtaining regulatory approval and ensuring readiness for the market. At MedPharm, we manufacture registration batches in GMP-certified facilities, ensuring that your drug product meets the highest standards of regulatory compliance, quality, and safety required for FDA, EMA, and ICH submissions. 

Our PPQ and validation batch programs help mitigate risks associated with commercial manufacturing by ensuring consistent, reproducible, and scalable production processes that meet critical quality attributes (CQAs) and regulatory expectations. 

Comprehensive Registration Batch Manufacturing Services 

Process Performance Qualification (PPQ) Batches 

PPQ batches confirm that your manufacturing process consistently produces high-quality drug products that meet regulatory expectations. 

• GMP-compliant production of PPQ batches for NDA, BLA, ANDA, and MAA filings 

• Verification of process reproducibility across multiple commercial-scale batches 

• Alignment with FDA, EMA, and ICH process validation requirements 

• Comprehensive batch record documentation for regulatory filings 

🔹 [Learn More About PPQ Batch Manufacturing →] 

Validation Batches for Commercial Launch 

Validation batches demonstrate that your commercial-scale production process meets predetermined quality criteria, ensuring consistent batch-to-batch reproducibility. 

• Validation of critical process parameters (CPPs) and critical quality attributes (CQAs) 

• ICH-compliant stability testing to confirm shelf-life and formulation integrity 

• Analytical method validation and real-time process monitoring 

• Full regulatory documentation support for marketing approval 

🔹 [Learn More About Validation Batch Manufacturing →] 

Regulatory & Quality Oversight 

MedPharm’s regulatory and quality teams work closely with clients to ensure that registration batches comply with: 

• FDA & EMA Guidelines for Process Validation 

• ICH Q8, Q9, and Q10 requirements for pharmaceutical development 

• cGMP requirements for commercial production 

• Global regulatory submission standards for NDA, BLA, ANDA, and MAA 

🔹 [Learn More About Our Quality & Regulatory Support →] 

Seamless Transition from PPQ to Commercial Manufacturing 

Once PPQ and validation batches are successfully completed, MedPharm ensures a smooth transition to full-scale commercial manufacturing, providing: 

• Ongoing process monitoring and quality control 

• Batch-to-batch reproducibility and efficiency optimization 

• Scalability for global commercial supply 

🔹 [Learn More About Our Commercial Manufacturing Capabilities →] 

Why Choose MedPharm for PPQ & Validation Batches? 

✅ GMP-Certified Facilities – Supporting regulatory-compliant batch production 

✅ Regulatory Expertise – Full compliance with FDA, EMA, and ICH process validation guidelines 

✅ Seamless Scale-Up & Tech Transfer – Supporting the clinical-to-commercial transition 

✅ Comprehensive Quality Oversight – Ensuring batch-to-batch consistency and regulatory approval 

✅ Full-Service Stability & Analytical Testing – Supporting regulatory filings and long-term stability studies  

Ensure Regulatory Success with MedPharm’s PPQ & Validation Batch Expertise 

With decades of experience in clinical and commercial manufacturing, MedPharm ensures that your registration batches meet the highest standards for regulatory compliance, quality, and safety, helping you achieve market approval and commercial success.  

Contact us today to learn how our PPQ and validation batch manufacturing services can support your drug product’s regulatory and commercialization goals! 

Quality and Regulatory-Focused Manufacturing

GMP Precision for Every Phase of Clinical Development 

In clinical development, every dose and every detail matters. At MedPharm, our Quality and Regulatory-Focused Manufacturing ensures that investigational products are produced with the same care, control, and compliance expected at the commercial stage. 

As a specialist Contract Development and Manufacturing Organization (CDMO) dedicated to topical and transdermal drug products, we bring extensive regulatory expertise and meticulous execution to every clinical batch. Whether you’re preparing for a first-in-human study or a Phase III pivotal trial, MedPharm provides manufacturing solutions built on reliability, transparency, and global regulatory alignment.  

What We Offer 

Our clinical manufacturing operations are designed for agility and precision, enabling seamless production of Investigational Medical Products (IMPs) under full GMP conditions.  

Key capabilities include: 

• GMP Manufacturing for Topical and Transdermal Dosage Forms: Products such as semisolids, gels, creams, lotions, ointments, solutions, and suspensions. 

• Phase-Appropriate Manufacturing: Adaptable batch sizes and documentation practices tailored for Phase I–III requirements. 

• Scalable Equipment and Cleanroom Facilities: Purpose-built suites for clinical-scale production and technology transfer compatibility. 

• Full Quality Control Integration: On-site analytical testing, in-process monitoring, and batch release support. 

• Global Regulatory Compliance: Manufacturing practices aligned with FDA, EMA, MHRA, and other international standards. 

• Audit-Ready Documentation: Comprehensive batch records, validation protocols, and quality assurance oversight to support regulatory filings and inspections. 

More Than Just Manufacturing—A Strategic Partner in Development 

We understand that clinical supply manufacturing involves more than just getting products out the door. It’s about laying the groundwork for regulatory success and commercial readiness. That’s why MedPharm’s manufacturing team collaborates closely with your formulation, analytical, and regulatory teams to: 

• Mitigate Chemistry, Manufacturing, and Controls (CMC) risks early on 

• Streamline documentation for Investigational New Drug Applications (INDs), Investigational Medicinal Product Dossiers (IMPDs), and New Drug Applications (NDAs) 

• Ensure seamless scale-up and future technology transfer 

• Deliver on-time, audit-ready clinical materials 

Why Choose MedPharm? 

• Decades of experience in clinical-stage topical product manufacturing 

• Nimble and responsive to sponsor timelines 

• Exceptional quality assurance and regulatory support integrated into every project 

• Transparent communication and collaborative problem-solving 

• End-to-end integration with formulation development and analytical services 

Manufacturing That Moves You Forward 

Your clinical program deserves more than basic GMP compliance; it deserves a manufacturing partner that prioritizes quality, regulatory alignment, and patient impact.  

Partner with MedPharm for clinical manufacturing that is precise, compliant, and designed to scale.