GMP Manufacturing

A comprehensive set of capabilities to support clinical studies.

API synthesis, spray dried intermediates, final dosage forms, and packaging.

Serán’s GMP facility is designed with highly-configurable cleanrooms to efficiently support a wide variety of manufacturing operations. Our cleanrooms are monitored to meet ISO 7/8 particulate standards. Our sanitization and microbial monitoring procedures ensure a safe and clean operating environment for your project.

Serán’s GMP activities are managed under a mature and compliant quality assurance system. Our QA team will work with you to ensure your project and regulatory requirements are met.

Our GMP capabilities include API synthesis, spray drying, blending, milling, granulation, capsule filling, and tableting. If you are developing a clinical asset, we have a variety of phase-appropriate processes to rapidly advance your drug to the clinic.

 


Your committed CMC partner.

Your drug is your future, but the path to a successful product is daunting. You need a CMC partner that’s as committed to your success as you are. Seràn offers a comprehensive set of drug-development services that begins with a detailed understanding of your project and goals. We deploy a science-based methodology that rapidly identifies a preferred approach that will enable an efficient  advancement of your drug to the clinic and beyond. Our science, quality systems, regulatory expertise, and customer service are second to none. 

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Let’s develop together.

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