We offer unparalleled formulation and product development services coupled with expert counsel and an emphasis on speed to market to keep your project moving in an efficient and cost-effective manner.
Our Product Development Services (PDS) team is comprised of more than 35 people, including 25 scientists, with decades of formulation development and analytical experience, supporting numerous NDAs, ANDAs, and pharmaceutical products. We take on brand-new projects (full formulation and development), pre-developed projects that need further scale-up or development, as well as fully developed or approved products, which we can move seamlessly from another site into ours. And with a sole focus on non-sterile liquids and semi-solids, our team possesses unmatched expertise in these dosage forms.
Development services and capabilities.
- Formulation development and product reformulation
- Process development, scale-up, optimization
- Clinical trial material manufacturing
- Site/technology transfer management
- IVRT/IVPT/Disease modeling for topical products
Project development history.
Project mix
- ANDAs – 63%
- NDAs – 37%
Approval mix
- ANDAs – 71%
- NDAs – 29%
Project mix
- Topicals – 73%
- Liquids and sprays – 27%
Analytical testing services and capabilities.
Our formulation development scientists work hand-in-hand with a team of analytical scientists during new product development and product transfers. We offer a complete range of testing services, from research and development to routine analytical testing, microbiological testing, in-vitro release testing (IVRT), and stability program management.
Analytical methods and testing.
- Analytical method development and validation
- Method transfers
- Forced degradation studies
- Cleaning method development and validation
- Product problem investigations
- IVRT (non-GMP and GMP)
Stability management.
- Six walk-in stability chambers at ICH conditions
- Reach-in, customizable stability chambers
- Photostability chambers
- Dedicated stability coordinators
- Remote alarm monitoring of chambers with back-up generators
Facilities.
- Non-GMP pre-formulation, formulation, and analytical labs
- GMP analytical quality control and stability lab
- State-of-the-art analytical and formulation equipment
- Dedicated pilot manufacturing suite for product scale-up batches (20Kg–300Kg batch size)