Research & Development
Strong energy and constant investment to grow our product portfolio
Big team of professionals with different backgrounds from the life science fields are devoted to the development of affordable products in a vast range of technologies, from injectables to oral solid forms and nasal sprays.
Our R&D operations are based in our R&D center of 300 m2 in Barcelona and a galenical laboratory built in 100m2 in GalenicumSAG facilities in Madrid, Spain.
Our approach to every development is a mixture of applying QbD standards and our knowledge on state of the art technologies, having always in mind the time to market for each of the products.
Once products are commercial, the life cycle management is also paramount and is continuously revised by this team of professionals.
Intellectual Property
One of the most IP active pharma companies in Spain
Galenicum Axium is an IP centric company. We take into account the IP situation and the opportunities derived from our IP research as one of the bases on which we decide to take on projects.
An internal dedicated team performs freedom to operate reports for all our developments and is a key player in the process of designing alternative formulations as well as supporting R&D in the entire development.
Galenicum Axium has already submitted more than 24 patent applications and is actively participating in oppositions with the aim to provide the most secure environment for our customers in the IP landscape.
Clinical affairs
Constant challenge to achieve the most suitable clinical strategies
This experienced team is devoted to design the clinical studies and make the appropriate clinical research needed for the success of our developments.
Our team has the know-how in clinical requirements for different markets worldwide and various types of products. Challenging clinical strategies are always evaluated to assure approvable and affordable products.
We collaborate with GCP compliant CROs, mainly in Europe and Canada. Galenicum Axium has a high success rate in bioequivalence studies, being our goal achieving the 85% success rate.
Regulatory affairs
Consistent relationship and knowledge of Agencies
Galenicum Axium’s regulatory team has extensive knowledge on the EU guidelines, USFDA, ANVISA and beyond, and vast experience in handling different type of procedures, including DCPs and MRPs in the EU market and National Applications in several markets.
This solution driven team has an excellent track record in both initial submissions and variations approved by the Authorities, reaching above 95% approval rates.
The attitude to find solutions as well as the know-how of the product and the Agencies is key to reach this service levels. So we can proudly say that we are a reliable partner in the regulatory space for our customers.
-
20
Feasibilities per year -
85%
success rate goal of bioequivalence studies -
5-10
Prototypes per year -
97%
RA initial submissions approval rate -
+24
Number of patent applications -
100%
RA variation submissions approval rate
