Formulation Development

We excel in offering pharmaceutical formulation development services by implementing customized strategies to fulfill our clients’ product needs. Our expertise ensures best-in-class results at every stage of the formulation development process and adherence to strict ICH guidelines.

Our Comprehensive Formulation Development Process

1. Preformulation Phase: 

To start the formulation development process, we conduct an extensive analysis of bibliographic data, review existing patents, and investigate 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. Specialty pharma expertise ensures that our methodologies align 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. Specialty pharma capabilities are pivotal in refining these processes to meet industry standards.

4. Scale-Up Phase: 

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

Formulation Development Services

Our formulation development services cover all aspects essential to successful pharmaceutical formulation development:

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