ABPharm expertise includes, analytical methodology, validation, drug characterisation, release testing and stability testing. We have a broad experience of development of API and a comprehensive variety of formulations and devices. We can assist you in all CMC related activities. Our objective is to be able to support you throughout the development of your product.
We can advise on Quality aspects, specifications, SOPs and Regulatory Guidelines. We can review, or prepare sections of your regulatory submission packages and help to identify potential issues and questions that might concern the regulators.
We have extensive experience with many analytical CROs and specialise in contracting out. If you have your own laboratories, we can review your methods and GMP/GLP procedures or carry out troubleshooting.
- All stages of Development, Clinical and Preclinical
- API, Synthesis Intermediates and Raw Materials
- Small Molecules and Biologicals
- Solid and Liquid Dosage forms including Parenteral.
- Devices including Inhalation
- Chromatography, Spectroscopy, Thermal methods
- Solid State Chemistry, Polymorphism, Particulates
- Outsourcing, Method Transfer and Audits
- Method Development, Validation
- Stability, Compatibility, Extractables and Leachables
- GMP, ICH guidelines, SOPs, Specifications
- Project Management and Training