Services
PSS extensive expertise in pharmaceutical development and our CROs/CDMOs Network uniquely position us as your partner of choice to meet all of your drug product development needs.
Additionally PSS can support Due Diligence processes and capable to provide project/portfolio and organisational interim management.
We are able to serve pharmaceutical projects that require a wide range of services including pre-formulation characterization, formulation development, analytical chemistry, stability evaluation, novel drug delivery systems, process development, and drug product characterization studies. Our expertise, our network capabilities and services are appropriate for programs from early to late-stage development through EMA/FDA approval and commercial launch. Our number one goal is to keep your development program on track.
Other Services
-
CMC Program Management
PSS has extensive experience in the creation of the chemistry, manufacturing, and control project plans to meet the strict EMA and FDA requirements for the different development stages (like INDs, NDAs, and commercialization). Our worldwide contract Development and Manufacturing Organization (CDMOs) network can produce cGMP drug products for global distribution for clinical studies and commercial use. We are experts in helping pharma companies, big and small, with their CMC regulatory submissions.
-
CMC Troubleshooting
Our vast experience of drug development consulting helps companies overcome challenges in formulation, analysis and manufacturing can help you identify not only the root cause of the problem but determine the appropriate solution and corrective action to get your development/product back on track. At PSS, we understand the importance the timelines. As experts in product development, product manufacturing, GMP, Quality, regulatory submissions, and regulatory affairs, we help companies in the pharmaceutical industry transfer innovative ideas into approved products.
-
Grant Application Support
For National and/or European grant funds
-Research and development project - expert service for the project applying for a subsidy and project implemented in the consortium.
-Creation Business plan, Identification of Work Packages
-Assessment of resources, timelines and costs
-Evaluation of project probability of success for funding