Ms. Mazó, MBA
QP - Site Manager
Mr. de la Fuente, PhD
Business Development Manager
Mr. Nicola, MSM
National Sales Director
Ms. Vázquez, PhD
Regulatory Affairs Director
Ms. Gambús, MD, PhD, MBA
Mr. Postigo, PhD
Contract Development & Contract Manufacturing Manager
GP Pharm’s manufacturing facilities are located in a 35,000 square meters area at Sant Quintí de Mediona (50 Km west from Barcelona).
Newly constructed in 2005, the site was projected to be expanded with the company's growth. Nowadays, the facility consists of 8 isolated buildings of which 3 exclusively dedicated to production and the rest are devoted to offices, labs, logistics and utilities. The R+D and Quality control laboratories are located in the same area to easy development and validation of analytical methods. The simultaneous presence of our R+D and Production teams allow GP Pharm to establish a close collaboration between them to guarantee a smooth transition between development and scale up of industrial procedures.
Our manufacturing site offers advanced manufacturing capability and a wealth of technological experience where everyday a team of committed and competent employees work to develop and manufacture safe and efficient pharmacological products. The facility specializes in the production and packaging of:
The excellence of our Manufacturing facilities has been widely certified by the Good Manufacturing Practice (GMP) approvals of several agencies (including EMA and FDA) which clearly demonstrates our commitment with stringent quality standards. According to this, GP Pharm facilities are GMP certified by the subsequent Regulatory Agencies:
The Medical department designs and conducts the complete pharmaceutical development of our medicinal products.
Our extended know-how in different areas guarantees the fully and holistic development from preclincal to Phase IV clinical studies.
Our people have expertise in validation of clinical assays, design and conduction of preclinical studies, pharmacovigilance, biomarker development and regulatory aspects. We account with PhD, MD and Master degrees professionals in our team.
We assure the quality control, fully compliance with SOPs and enforce regulations and guidelines during all phases of the pharmaceutical development.
GP Pharm’s medical department assures the safety of the medicinal products (during the entire development and post-authorization) by the active monitoring of all pharmacovigilance aspects.
GP Pharm recognizes that a comprehensive intellectual property portfolio is of substantial value. It has developed original products and technologies and has generated an effective patent portfolio by focusing on obtaining quality patents that cover key products and technologies.
GP Pharm’s patent portfolio counts more than 100 individual patents and patent applications in about 50 different countries worldwide. Key products and technologies, such as controlled release systems, are protected by high value patents in the most important markets.
In order to ensure the proper storage of medicinal products under authorized conditions in GP Pharm warehouses a full integration of the supply chain from receipt, identification, storage, order preparation, documentation, shipping and distribution is made, keeping in any time a perfect traceability to product delivery to the customer.
GP Pharm is specialized in temperature controlled shipments worldwide, whether it is at room temperature (<25˚C), chilled (between 2˚ and 8˚C) or frozen (-20˚C) conditions. We work with the best suppliers of active and passive cold systems, choosing for each shipment the system that best ensures timely delivery and product quality.
The company also handles the export documentation according to the different regulations of each country in order to facilitate the process of importing the client and ensure a quick delivery to different destinations.
GP Pharm has a Regulatory Affairs Department with vast experience in national, European and US procedures.
The regulatory affairs capabilities of GP Pharm include:
Our Regulatory Affairs Department provides continuous support to our clients ensuring high-quality and timely registrations.