Accurate and precise analytical results
when you need them.
From early strategic investigative work on possible formulations to the development and implementation of methods and the generation of regulatory submission data, our team of experienced scientists will work – and communicate – with you at every step. We offer preform, drug characterization, method development, validation and stability testing services to meet your challenging analytical needs and timelines in a cGMP-compliant laboratory.
Following an agreed-upon formulation strategy, we perform preformulation studies to generate data that will lead to the key valuation milestones for your drug candidate. These studies may include the characterization and determination of the following:
In today’s age of QbD, an early understanding of the physiochemical properties of drug substances, excipients and finished products is crucial. Through the use of advanced analytical testing systems, Ropack Pharma Solutions provides strategies for the optimization of your drug product development.
Our cGMP lab performs method development and validation for a broad spectrum of pharmaceutical compounds and dosage forms during various drug development stages, including methods for:
We can support your product through its lifecycle from pre-IND to commercial product, including routine analysis such as CTM release and stability testing.
ICH-compliant stability storage temperatures and, where applicable, humidity control, with many intermediate options available.
Ropack Pharma Solutions is driven by quality, scientific expertise and customer communication to ensure that your drug candidate is given the best path to market.