Custom synthesis
We offer custom synthesis services for your project needs, whether it’s synthesizing a critical intermediate, a reference standard or impurity isolation or API synthesis to keep your CMC activities on track. Our vast experience and knowledge of chemical development, will help navigate your project to meet the intended timelines. Our goal is to be cost effective, by identifying ways to improve your synthesis. Our vast experience and knowledge in the industry will help navigate your project to meet the timelines and demonstrate cost effectiveness.
Contract Research Services
We also offer drug discovery services using our expertise in medicinal and synthetic chemistries. We have a strong team of talented and experienced chemists, who bring value from working with global pharmaceutical companies.
Manufacturing services
We manufacture API’ and advanced intermediates, keeping quality and cost as the forefront of our business. We also offer customer tailored manufacturing based on program needs and timelines.
Chemical Developments
We have extensive accomplishments, background and experience of process chemistry and scale up, for different phases of drug development. We develop processes tailored for the end use and involve customer in every stage of chemical development.
Program Management
We manage chemistry and manufacturing activities with external CMO’ for small and virtual biotech’s for their drug substance supply needs. The details of this offering can be discussed based on the company needs and phase appropriateness.
Process validation strategy and implementation
Designing validation, based on CPPs, risk mitigations, PFMEA analysis and historical GMP results is imperative. We offer in-depth analysis of your process validation strategy for drug substance (API) to ensure smooth execution.
FTE Program
We will dedicate chemists to perform customer projects and conclude the results based on predefined terms.
Technology Transfer
We also help steer projects from external CMO and perform a technical transfer of the process. Evaluate the feasibility for “as is “ Vs need improvement plans. Any findings identified during the technology transfer will be documented and discussed with customers for action.
Reference standard
We will synthesize reference standards based on the phase of your drug development. This can be purification or synthesis or both.