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Message from the CEO

“Only investment in R&D and education generates the desired wellbeing of the people, and this is something that we must integrate to continue for another 200,000 years on this marvellous planet.”

“Your success is our success”

It is my pleasure to welcome you to the QualitecFarma® website, the reference company based in Spain for pharmaceutical services to the industry.

Since 2000, the company has been growing in the effort to offer the bio-pharmaceutical industry worldwide support to face the challenging development projects that the global drug markets are demanding.

From the beginning, the aim of our organization has been to offer a solid and robust answer to the drug development needs of our clients around the world. The company has operations in all the EU countries, LATAM and US, covering all aspects related to the clinical, regulatory, pharmacovigilance, and business issues that the companies require to succeed.

Our team is the most experienced and challenge focused as this has been our leitmotif since the beginning, to grant the best results for the client’s success while working in complex and highly qualified environments.

We believe in a win-win philosophy as our company is a product of this way of thinking. Only the success of our client will mean our own development and growth, and therefore we work on specific isolated projects or run the race in parallel with our clients.

Together we can identify all the key strategies you need. Think on it, and let our contribution unleash your project’s maximum potential and success.

Your success is our success.

Óscar E. Mesa del Castillo


a CRO with a business model that gives high-quality value

QualitecFarma® is a Contract Research Organization (CRO) with headquarters in Madrid and offices in the US. We provide value-adding consultancy and support services to the bio-pharmaceutical industry. Our area of work is focused on clinical trials, clinical and post-marketing pharmacovigilance, regulatory affairs, strategic development, and search for business opportunities for our clients.

from the beginning up to the last stage of scientific and clinical research

We participate from the beginning up to the last stage of scientific and clinical research and the selection of active ingredients and suppliers, submission, follow-up, and final granting of Marketing Authorisation, according to our clients’ requirements.

Our QMS complies with the latest GCPs on international standards, as the rest of our services are ISO9001/2015 certified from Regulatory Affairs to Pharmacovigilance. Quality is our master commitment with support and trustworthy service to our sponsors and clients.

multidisciplinary staff qualified for giving a fully functional quality service system

The company has a multidisciplinary staff specially qualified for giving a fully functional quality service system to the specific requirements of each company. The QualitecFarma® team is made up of experienced professionals, pharmacists, physicians, chemists, biochemists, and lawyers who work to optimise the resources of biomedical sector companies, allowing effortless flexibility to meet our clients’ needs.

Why choose us

With deep knowledge and high expertise in clinical research, our qualifications allow us to adapt to our clients’ operational and strategic needs, ensuring their success and research promotion.

Our Commitment

In this line of work, the greatest contribution is also the most gratifying reward; improving patient health through clinical research.

Quality is a major key factor, as it is the neural network of each solution in every project commissioned to us by our clients. As a CRO, our commitment to our work is crucial to the part we play in helping to deliver revolutionary medicine to those who need it.


A glimpse at the start

The year 2000 brought to light a long-standing passion to contribute to the healthcare of people around the world. Providing scientific support services in regulatory affairs, pharmacovigilance, and strategic business, QualitecFarma® blossomed into the drug development industry.

Grow and innovate

Always on a mission to grow and innovate, our Research and Clinical Strategies services were thereafter structured, adding on a diverse and qualified team to help in the development of the best strategy to achieve Phase I to IV trials.

Two Decades of Progress in Drug Development

During these past two decades the growth in diversity and numbers of our clients has solidified our foundation as a company. It has been the major player in the consecutive milestones in our story, for every role we have played and continue to play in the lifecycle of medicine and in varying international government environments.

For the future of patient health

Today, QualitecFarma® is a leading CRO committed to the future of patient health through scientific and clinical development, helping innovative products reach the market,, and always upholding high quality standards on every endeavour.

The Road Ahead

“In this Digital Age, QualitecFarma is seizing each opportunity of advancement in clinical research, always adapting to the latest state-of-the-art digital tools at our disposal, with the ultimate goal of improving patient health.”

Quality Policy


QualitecFarma®, S.L. was created at the end of the year 2000 with the aim of providing highly qualified services to the pharmaceutical and bio-sanitary industry to give support to all their needs. The company’s field of work focuses on clinical research, pharmacovigilance, regulatory affairs, strategic business development and search for business opportunities for our clients.


We stand as a reference in this sector through management under a total quality standard and continuous improvement.

  • Awareness in the practice of error-free work, loyal commitment to the company, and with the activities developed.
  • Improvement in competitiveness and quality versus other companies in the sector.
  • Offer a high-quality service, with dynamism, thanks to smooth communication with our clients.
  • To responsibly assume all the functions necessary to meet the required quality standard, also guaranteed through a complex but effective QMS.
  • Create a favourable environment for personal and professional development of the staff.


Compliance with all applicable requirements that a QMS demands in terms
of clients, interested parties, legal and other general requirements that apply to our services.

  • Define in a clear manner the service to be carried out according to punctual needs of the client.
  • Tasks, process and strategies planning.
  • Continuous improvement in documents management.
  • Establish collaboration areas with other entities or companies that could be interesting.
  • Optimize costs and questioning results, regarding the satisfaction level of our clients and interested parties.
  • Maintaining a high level of training and motivation for the whole staff; so that knowledge and client focused service, are the key of the trust on us.
  • Full commitment with Quality and continuous improvement.

The Directorate of QualitecFarma spreads this policy to the entire organization; and allocates the necessary resources for employeee training, the understanding and compliance with this policy.