other services

Multi-Disciplinary Projects

As a company with a wide range of experience, particularly in the development field, we are used to working in multi-disciplinary teams across the UK and well beyond.

For more information:
Call: +44 1274 326073
Email: answers@agenda1.co.uk

Pharmaceutical_Manufacturing_Top_09052014

Pharmaceutical Manufacturing

As large pharmaceutical companies outsource both ancillary services like analytical work, and even the full scale manufacture to specialist companies, we find ourselves working with both types of companies. Our support has included:

  • Method Development and Validation

    Developing and validating methods “fit for purpose” to meet regulatory / investor needs. Our support in this area has included developing and validating procedures using XRD, XRF, ICP, GC, GC-MS, HPLC, UV, FTIR, Particle Sizing, Surface area, and many others.


  • Stability Studies

    We have a wide range of facilities available to meet ICH Conditions for R&D and Commercial product stability studies. Short term physical stability studies are a particular focus, supported by our XRD, TGA, DSC, particle size, Porosity / surface area. Our support can include the design of the stability study.


  • Method Re-Validation

    Regulatory focus on methods is increasing and there is a growing need for older methods to have additional evidence of validation and/or to be improved and revalidated. We have carried out a wide range of programmes in this area.


  • Cleaning Validation and Verification

    We have good experience in developing Cleaning Validation/Verification methods and protocols and can advise and comment on the attendant swabbing procedures.


  • Raw Material Release Testing

    Our experience in Method re-validation brought with it a wide range of raw material testing techniques which we continue to add to, our capabilities include the vast majority of Ph. Eur Raw material testing monograph procedures.


  • API Release Testing

    These tests fall quite naturally from the method validation work above. We are particularly skilled in pulmonary product API testing, supported by our wide range of specialist equipment applicable in this area.