Services
Learn more about what Agno Pharmaceuticals can do to help you accomplish your goals.
Process Development
Full Characterization Report
Impurity Identification
Forced Degradation Study
Reference Standard Preparation
Process Safety Evaluation
Manufacturing Facilities Worldwide
With manufacturing facilities strategically located across various regions worldwide, we are uniquely positioned to offer both time-sensitive and cost-effective solutions tailored to your RSM needs. Our global presence allows us to efficiently manage production and logistics, ensuring that your RSM requirements are met with precision and agility.
Our commitment to excellence means that we can not only meet but exceed your expectations. We are equipped to develop innovative technologies and establish new supply chains as necessary, ensuring that your specific needs are addressed effectively. Whether you require standard processes or bespoke solutions, Agno Pharma is dedicated to delivering high-quality results.
Our suite of RSM manufacturing services
- Process Development: We will work closely with you to develop and optimize the most suitable manufacturing processes for your RSM. Our team utilizes cutting-edge technologies and methodologies to ensure that the process is efficient, scalable, and compliant with regulatory standards.
- Impurity Identification: Identifying potential impurities is crucial for ensuring the purity and safety of the RSM. Our experts conduct thorough analyses to detect and characterize impurities, helping to maintain the integrity and quality of the final product.
- Reference Standard Preparation: We prepare reference standards, typically around 100 grams, which are essential for quality control and validation purposes. These standards are critical for ensuring consistency and accuracy in the manufacturing process.
- Full Characterization Report: Our comprehensive characterization reports provide detailed information about the RSM, including its chemical and physical properties. This thorough analysis is vital for regulatory submissions and quality assurance.
- Forced Degradation Study: To evaluate the stability of the RSM under various stressed conditions, we conduct forced degradation studies. These studies help to understand the material’s behavior and stability, ensuring its reliability throughout its shelf life.
- ICH Stability Study: We perform stability studies in accordance with International Council for Harmonisation (ICH) guidelines. This ensures that the RSM remains stable and effective throughout its intended shelf life and meets all regulatory requirements.
- Process Safety Evaluation: Assessing the safety of the manufacturing process is a key aspect of our service. We conduct rigorous evaluations to identify and mitigate potential risks, ensuring a safe and compliant production environment.
- Nitrosamine Assessment: Our nitrosamine assessment services focus on evaluating and controlling nitrosamine levels in the RSM. This is crucial for ensuring that the product meets safety and regulatory standards, particularly given the recent increased scrutiny on nitrosamines in pharmaceuticals.
Partner with Agno Pharma to benefit from our expertise in RSM and intermediate manufacturing. Our dedicated team is committed to providing you with high-quality, reliable solutions that adhere to the highest standards of regulatory compliance.
