Moldons Pharmaceuticals UK Analytical Solutions™
Through Moldons Pharmaceuticals UK Analytical Solutions™, we support customers with stand-alone analytical requirements. Our analytical development team has experience from developing hundreds of analytical methods every year, supporting development of formulations ranging from powder in capsules and IV solutions to ER tablets and dry powder inhalers. This means our 160-strong team of chemists are prepared for any challenge.
The size and flexibility of our labs enable rapid project initiation and parallel activities to be performed. Combined with our track record and expertise, our offering can help decrease time-to-market. At Moldons Pharmaceuticals UK, we have several state-of-the-art laboratories and stability chambers enabling more than 250 concurrent ongoing stability studies. By utilising our expertise, we help clients to combat resource challenges while reducing timelines and costs.
Our dedicated analytical team offers pharmaceutical companies access to expert solutions for:
- Analytical method development
- Analytical method validation
- Stability program design and analysis
- Pharmacopeial testing and verification
- Upgrading of outdated methods
- Extractables and leachables (E&L)
Why Moldons Pharmaceuticals UK Analytical Solutions™?:
- We have the capability and scale to take on analytical projects, freeing up customer QC and analytical laboratories.
- Our capacity, experience and flexibility in handling vast stability programs is well proven.
- We adopt a QbD approach to guarantee high quality, robust and transferable methods.
- With a focus on innovation, we can help customers to increase speed to market.
- We have a 160-strong team and extensive analytical equipment.
- We offer a flexible approach and are equally happy to develop methods for a single project as we are to dedicate a full lab to one customer.
- Our team mitigate risk by operating in the centre of the entire drug life cycle being fully aware of regulatory demands in different development stages as well as the challenges during the tech-transfer of analytical methods. This means we can help to mitigate risk.
- We have expertise in specialist analytical techniques including all dissolution types, in vitro permeation testing/in vitro release testing methods (IVPT/IVRT), extractables and leachables (E&L), as well as performance testing of inhalation products.
- We have in house chemistry laboratories with strong experience in identifying impurities and synthesising standards.
- We offer a quality release service, also called EU release, to pharmaceutical companies situated outside of the EU.