Solid State Analysis

Polymorph Identification,
Physical Form,
Raw Material Identity,
Surface Area, Particle Size

Assay and Quality Control

Stability, Dissolution,
Potency and Impurity
Analysis, Residual
Solvents, Changes in
Physical State,
Environmental Monitoring

Ongoing program support

IP Filing,
Product Release
Testing, Bioburden,
QA Release, cGMP.

Irrespective of your industry, certain core questions are repeatedly raised: What size are the particles we are working with? What shape are they? How porous are they? What sort of surface area and characteristics do they have? Agenda1 can help answer those questions. In the Pharmaceuticals world (and in others) follow up questions include concerns over physical state (amorphous or crystalline materials) or the polymorphs present - again we are equipped to answer those questions.

As you optimise your formulation or process, you need data quickly to understand the impact of the changes you've made. Whether you are interested in seeing how the dissolution behaviour has changed, if the drug content has been compromised, if the level of residual solvents has increased, or determining the impact on storage stability, we have the ability to support you, and the skills and experience required to deliver good data quickly. 

Your goal might be to out-license your product, or to manufacture it in-house and market it yourself. Whatever the case, we can help by ensuring high quality data is available for a sales packs, or that QA-reviewed data (as required by cGMP) has been generated and securely archived. Our equipment is maintained and qualified to specified quality standards, with a detailed audit trails for both equipment and operators, and complete traceability for your data.