QualitecFarma® is one of the most recognized Scientific Regulatory Affairs consultancy companies based in Spain. With more than ten years background experience in this field, we have worked with most of the biggest pharmaceutical companies in Spain and abroad.
QualitecFarma® has expertise in all therapeutic areas and product types. We offer full regulatory support with a comprehensive portfolio of regulatory services including:
- Gap analyses for all submission types (Centralised, Decentralised, Mutual Recognition or National routes of filing)
- Marketing Authorisation Applications, Variations, Line Extensions and Renewals
- Quality, non-clinical and clinical data packages
- CTD modules - Dossier compilation, updates and conversions
- Handling responses to questions following agency reviews
- Post-Approval Maintenance
- e-CTD and non-e-CTD submissions
- Clinical Trials applications
QualitecFarma® can act as a complete "virtual" regulatory affairs department for clients who decide to outsource the regulatory affairs function.
We are also an approved pharmaceutical laboratory and therefore we can act as Marketing Authorization Holder for as long as it is required by the client.
Our clients comprise both local (Spanish) and international pharmaceutical companies who are willing to improve and develop their regulatory strategies, making them able to approach foreign markets across the EU, Central and South America (where we are actively working) and through our partner, in China.
Our team of professionals has vast regulatory affairs experience gained in pharmaceutical companies of all sizes and we fluently work in English, Spanish and Italian (being native-speakers).
We provide a comprehensive range of professional regulatory services, which are tailored exactly to our clients' needs (based on the type and dimension of the project). Contracts may range from one-off project work with an hourly rate, through to complete regulatory affairs outsourcing.
QualitecFarma is the Samarind RMS partner in Spain.
For further information please contact:
QualitecFarma
C/ Ochandiano, 10
CE El Plantío, Edif. 10, 1ª plta
Madrid 28023 (Spain)
T: +34 91 372 83 99 / 84 00
F: +34 91 372 84 04
E: formacion@qualitecfarma.com
www.qualitecfarma.com