We offer a broad range of development services to advance projects all the way from your initial idea to a Marketing Authorization.
According to our procedures for drug development we plan and manage the project with milestones, and support your needs for documentation, supply chain and quality assurance.
We advice your regulatory strategy, liaise with authorities and take care of quality agreements and supply contracts while compiling the dossier and ensuring a smooth application process.
We do sourcing of APIs, excipients and packaging materials, IMPs, nIMPs , in addition to auditing and approval of suppliers.
Based on your needs, we can support your clinical trial planning, IMPD and protocol writing; we take care of agreements and coordination of service providers an establish the product specification file.
We offer expertise and manufacturing services all the way from test batches, clinical trial batches and scale-up to commercial production / tech transfer, supported by all necessary qualification and validation.
If needed, we can support your formulation development and manufacturing process, with all necessary trouble shooting involved. Control of starting materials and finished products in included, as well as stability studies.
We can support most of your needs in clinical trial support: comparator sourcing, production, packaging, labeling, blinding, distribution, stability studies and QP services.