GMP & CMC laboratory testing

Our GMP and CMC laboratory testing services help you better control your molecule and confirm its safety through analysis of the product and manufacturing environment.

 

It is vital to produce drug products in accordance with GMP and CMC standards in order to demonstrate that your product is safe and effective. RSSL can support you with lot release testing, environmental monitoring and impurity testing in response to the latest regulatory changes.

 

RSSL’s services employ experienced teams and highly sensitive instrumentation in a GMP environment to carry out the tests you require in line with the latest regulations. As well as conducting testing in-house, we have an array of training courses that give you the skills to take ownership of your environmental control.

Pharmacopeia and Monograph Testing

 

Our pharmacopeia and monograph analytical expertise ensures that pharmaceutical products meet the highest standards of quality, purity, and compliance. RSSL’s deep understanding of global pharmacopeial standards such as the USP, EP and JP ensures your products adhere to all necessary regulations. We offer specialised services in monograph method development, validation, and custom analytical solutions to support pharmaceutical projects at any stage.

 

We use state of the art analytical techniques such as HPLC, GC, and mass spectrometry to deliver accurate testing for identity, potency, and purity. Additionally, our regulatory experts keep up-to-date with changes in pharmacopeial standards, ensuring seamless compliance with evolving global requirements.

 

As your trusted partner, RSSL offers a full range of pharmacopeia services. With decades of experience, we help you navigate the complexities of regulatory processes, avoid costly delays, and accelerate time-to-market, all while safeguarding the safety and efficacy of your pharmaceutical products.

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