Orphan drugs address serious unmet needs. Increased focus on the development of targeted therapies and personalized medicine has been central to the development of many orphan drugs. The need for treatments for patients with thousands of orphan diseases remains. However, due to the small market size, streamlined development is important to ensure speed to market and return on investment.
Our Bench to Clinic Fast© approach to development and client-centric mentality makes Pharmatek an ideal partner for the development of orphan drugs and other fast track products. These projects not only require development expertise, but also access to a range of equipment that fits these small market size products and an ability to meet their accelerated timelines. Our goal is to create a formulation, manufacturing process and analytical methods which enable rapid IND approval, while also facilitate accelerated NDA submissions.
Orphan Development Capabilities:
• Oral Dosage Forms
• Dosage Form Development
• Analytical Development
• GMP Manufacturing
• Analytical Services
• Packaging, Labeling & Distribution
• Stability Testing & Storage
• Solutions for Poorly Soluble Compounds
• Highly Potent & Cytotoxic Compounds
Orphan drugs require expertise in formulation and process development and a sense of urgency that many CMOs are not prepared to handle. Our experience with formulation and process development combined with our speed and flexibility ensure projects will progress into Phase III trials smoothly. Our flexible scheduling and size means you will not be ignored due to larger scale projects.