Documentation
Analysis of the technical, market & patent situation
In this field, you may call upon our extensive knowledge and expertise with regard to all issues of polymers, cells, engineering aspects, and you may gain advantage from our analyses of the market, techniques and the patent situation. If required, proposals for ways out and around any difficulties, including development, product and marketing strategies, or guided patent writing, are made.
Guided regulatory affairs
Interaction with the european authorities with regard to regulatory affairs is our domain. Lay back and enjoy to watch your product coming through the regulations toward the market.
We offer interaction with the authorities, guided installation of the requirements
(SOPs, quality, documentation), compilation of the documentation for the authorities
(CTD), follow-up of your products, and editing of all required additional information
(enclosed labels, adverse events).
Medical technology
In this field, you may call upon our extensive knowledge and expertise with regard to all issues of polymers, cells, engineering aspects, and you may gain advantage from our analyses of the market, techniques and the patent situation. If required, proposals for ways out and around any difficulties, including development, product and marketing strategies, or guided patent writing, are made.
Pharmaceutical
In this field, you may call upon our extensive knowledge and expertise with regard to many issues of the overall lifecycle of a pharmaceutical product, from research and development through final testing, regulatory affairs and official approval to the production, throughout the value chain. You may gain advantage from our analyses of the market and patent situation.
If required, proposals for ways out and around any difficulties, including
development, product and marketing strategies, or guided patent writing, are
made.
Special expertise:
- Innovative pharmaceuticals (targeting), also based on modern biomaterials (biopolymers, microparticles, gels, liposomes, membranes, melt extrusion, taste masking, complexes, cell products, scaffolds)
- Immunology, oncology, inflammation, pulmonary tract
- Phytomedicines