Tergus Pharma and MedPharm are now one company!
+
The two premier topical experts have joined forces to create the world’s leading topical CDMO with global reach, experienced leadership, strong financial backing, and expanded end-to-end capabilities from early stage development through full commercial production of topical drug products.
Click here for the official press release.
Because of our sole focus on topicals and transepithelial drugs, we are uniquely positioned to guide you down the final stages of the development path while ensuring the highest level of quality and regulatory compliance.
Product Characterisation and Specification
Once a formulation has been selected, MedPharm supports clients by defining the full product characterization with validated methods appropriate for the phase of development. The key focus is to create release and stability specifications that ensure the product’s quality without unnecessary complexities. MedPharm will ensure the specifications are relevant to monitoring the Critical Quality Attributes of the product.
Our process development experts are uniquely placed to predict and mitigate risks during the scale-up of the formulation. This is critical to achieving consistent product performance and quality at a stage of fundamental importance on the road towards commercialization.
Process development aims to establish optimal manufacturing conditions for a pharmaceutical product and ensure that it meets both quality and regulatory standards. MedPharm’s long experience in scale-up has shown that investigating early in understanding the process can prevent potentially expensive issues occurring during the supply of clinical batches and when starting commercial supply.
MedPharm uses the Quality by Design (QbD) principles outlined in ICH Q10 in the design and scale-up of any formulation. Combining an understanding of a product’s Quality Target Product Profile (QTPP) and subsequent Critical Quality Attributes (CQAs) with MedPharm’s years of experience, our scale-up team will recommend an efficient set of small scale experiments to test the sensitivity of the product to any Critical Process Parameters (e.g. mixing rate, cooling rate, etc) they have identified. The data maps out any critical limits of these parameters and ensures that subsequent batches can be made with consistent quality.
Process Development, QbD and Scale Up
Phase II & III Clinical Trial Material
When success for your topical product’s clinical trial depends on hitting milestones and keeping to a tight schedule, you want a manufacturing partner with deep knowledge and comprehensive technical capabilities for topical formulations. MedPharm will expedite your drug development program through effective and efficient production of clinical trial materials. Our formulation scientists and manufacturing teams work together with you and/or your Clinical CRO to assist with technology transfers for late-phase clinical trial material batches.
Stability indicating methods are established early in the development process and can be appropriately validated for full-scale batch testing.
In order to simplify the compilation of a client’s regulatory submissions, all data is provided in IMPD/IND/CTD format. MedPharm provides stability testing in all ICH zones.
ICH Stability
Registration Batches
Registration batches are essential for obtaining regulatory approval, as they demonstrate the consistency, quality, and reliability of the manufacturing process. By leveraging state-of-the-art facilities and stringent quality control measures, we ensure that every batch meets the highest industry standards, paving the way for successful product commercialization.
MedPharm will provide you with documentation for registration batch manufacturing that ensures transparency, compliance, and provides a comprehensive overview of the manufacturing process to support your regulatory approval and commercialization efforts.