Development of solid-dose formulations, project management, production strategy and due diligence.
PDS has over 20 years experience in the field of pharmaceutical development for solid dose products. This includes tablet development, stability testing, CMC project and regulatory strategy and implementation. PDS has developed and implemented chemistry and pharmacy regulatory strategy for compounds from preclinical phase to NDA/MAA approval.
PDS has proven experience in working with clients to develop their pharmaceutical development, and manages development projects on behalf of clients. This can include working with contractors, identification of project milestones and objective timelines. PDS can establish the maintenance of operational project groups and effective communication channels, and implement project tracking measures and real-time monitoring and reporting.
PDS can advise on production strategy for new products in the EU and US, and provide development and packaging strategies. R&D and marketing can be advised on the optimum ways of presenting and packaging a product for global supply.
Technical due diligence can be undertaken for potential licensing opportunities. This includes chemistry, manufacturing and control, preclinical, and clinical due diligence. The transfer of product knowledge from licensor to licensee can be facilitated. PDS also offer an expert witness service, for advice and guidance on the resolution of legal disputes. These can range from formulation, safety, control and regulatory issues pertaining to patents.
PDS provides consultancy in preformulation studies and can advise on all technical issues prior to formulation development.
PDS has a network of consultants to enable PDS to have access to a range of expertise and capabilities. This enables PDS to meet demanding client requirements and to fulfil the requirements of projects.
PDS consultants regularly speak on technical and scientific material at conferences, such as AAPS and the Royal Pharmaceutical Society of Great Britain. The range of in- house expertise enables PDS to present on a range of topics, and presentations are tailored to the requirements of the audience. PDS also run bespoke in-house training courses. These are particularly useful for non EU companies that are intending to launch products in the EU.