Formulation Development

We excel in offering drug development services, implementing customised strategies to fulfill our clients’ product needs, guaranteeing top-notch outcomes at each stage of Development, and maintaining strong Manufacturing processes.

Our Comprehensive Development Process

1. Preformulation Phase: 

To start the formulation development, we begin with an extensive analysis of bibliographic data, review of existing patents, and an in-depth investigation of the most relevant physicochemical properties of the candidate drug substances. 

2. Development Formulation Phase: 

In the next phase, our team undertakes meticulous screening and optimization studies, specifically crafted to match the distinctive attributes of the project. This approach equips us with the detailed information required to define the optimal composition. Our clients can be confident that our methodologies are in strict accordance with the latest ICH guidelines, incorporating the principles and tools of Quality by Design (QbD). Throughout the development phase, we utilise statistical experimental design and risk assessment techniques. Furthermore, the development of analytical methods constitutes a crucial component of this phase, ensuring comprehensive and precise results.

3. Process Development Phase: 

Cutting-edge equipment is employed to simulate industrial-scale processes, challenging critical process parameters to establish robust and transferable processes. This flexibility aids in the seamless transition from R&D to production scale.

4. Scale-Up Phase: 

Our team proficiently manages scale-up tasks to reduce the risks associated with technology transfer.

Excellence in Drug Formulation 

We are dedicated to achieving our clients’ objectives by providing high-quality, efficient, and cost-effective solutions in formulation development.

Our expertise in formulation development enables us to design premier development strategies precisely tailored to our clients’ needs. Employing advanced methodologies, we deliver superior formulations and robust manufacturing processes designed to meet your specific goals. Specialising in accelerating our clients’ products to market, we never compromise on quality.

From the initial preformulation stage to scale-up, our adept team is prepared to handle every complex aspect of the development cycle. Equipped with state-of-the-art technology that simulates industrial-scale operations, we offer the flexibility necessary for a seamless transition from R&D to production scale.

Services:

• API characterization
• Preformulation
• Formulation development
• Analytical method development
• Process development
• Technology transfer
• IP Search