Resourcefulness + Dexterity + Expertise = Results
At EnDev, our job is to create “what’s next” in the world of therapeutic skin care and prescription dermatological products.We use our collective experience and expertise, along with a willingness to embrace the unconventional, to follow the science until it takes us where we want to go.
When it comes to new product formulation, there are no cookie-cutter solutions. It requires creative thinking, a mastery of scientific principles, and the ability to never take no for an answer. That’s how new products are born, and why we’re able to so successfully transform our clients’ ideas into the products they envision.
Capabilities
While we have very deep experience in dermatological product development, our core skill is partnering with you to bring your idea or product to life. To accomplish this, we combine the following services with effective project management:
Development Services
Formulation and Process Development
The gap between an idea and its execution doesn’t care about anyone’s pedigree. Nowhere is this more apparent than in the development of a formulation. That’s why we use a multidisciplinary approach that is broader than industry standard. This makes us good with unusual problems, which is important, because when you work in the gap between concept and reality, you don’t always get to know what kind of problem you are facing until you are in the middle of it.
Capabilities
- Pre-Formulation
- API Characterization
- De Novo Formulation Development
- Reverse Engineering
- Process Development
- Particle Size Method Development and Validation
- Microscopy Method Development and Validation
- Advanced Rheometry
- Special Studies
Analytical Development
What do we know? How do we know it? How well do we know it? These questions are the foundation of our analytical services and why we say, we are scientists doing drug development rather than drug developers who have borrowed the tools of science.
We have a full complement of analytical methods and tools in place, but our rigorous, multidisciplinary approach also gives us the ability to handle very complex and unusual problems. When trying to bridge the gap between the actual and the possible, you can never be too accurate or too right.
Capabilities
- Product Assay Development and Validation (UPLC, HPLC, GC, and ICP)
- API Assay Development and Validation (UPLC, HPLC, and GC)
- Residual Solvents Analysis
- Photostability
- Antimicrobial Assay
- Microbial Limits
- Preservative/Antimicrobial Effectiveness Testing
- Impurity Identification (Mass Spec, NMR)
- ICH Stability Testing
- In-Use Stability Studies
Technology Transfer
We work hard, in a smart and efficient manner to help you realize the maximum value when outsourcing. We ensure a seamless transfer of internally or externally developed products into our manufacturing facility. By incorporating Design of Expermiment (DOE) methodologies, Quality by Design (QbD) principles, and Technical Risk Assessment (TRA) strategies, typical transfer challenges are managed proactively and the result is a robust and efficient manufacturing process.
Capabilities
- Process Optimization
- Process Transfer
- Packaging Development/Engineering
- Scale Up
- Pilot Plant
- Manufacturing Risk Mitigation
- Clinical Supply Manufacturing
- Registration Batch Manufacturing
Regulatory Solutions
Regulatory approval is part art, part science and a dash of bureaucratic know-how. Helping your product clear this gap, the first time, without retesting or reformulation is our goal. Having helped many clients through this process, we have substantial experience dealing with the FDA. We can handle every aspect of your approval on a turnkey basis, or provide you with the timely analytical information required to handle it yourself.
Capabilities:
- Abbreviated New Drug Application (ANDA) Compilation and Filing
- Chemistry, Manufacturing, and Controls (CMC) Technical Section Compilation
- Supplemental Drug Applications
- Regulatory Strategy
- Drug Monograph Interpretation and Guidance
- OTC and Cosmetic Labelling Compliance
EnDev Leadership Team
Jean-Philippe Therrien, Ph.D.
Vice President, Skin Biology
Charles W. Gray, Jr., Ph.D.
Site Head, Kannapolis (EnDev)
Vijendra Nalamothu, Ph.D.
Chief Executive Officer
EnDev Laboratories is a wholly owned subsidiary of Tergus Pharma, a full-service Topical CRO.
Tergus, an end-to-end service provider for topical pharmaceutical research, drug development, testing and manufacturing company, has been an industry leader for several years with a state-of-the-art facility in Durham, North Carolina. The company has a long and stellar reputation for delivering quality results to clients from formulation through manufacturing, which is why people say, “Think Topicals, Think Tergus.”
