KNOW who we are
About Us
Pharmaceutical Innovation Services, S.L. is a company founded in 2009, specialised in offering a fully integrated service throughout the entire life cycle of the drug, from the initial phases of development to authorisation, market maintenance, quality, pharmacovigilance and regulatory compliance.
WE ARE
Since May 2023 we have been a MAH (Marketing Authorization Holder), and we offer the same service to our customers. In addition, we are a strategic consulting company with a team that brings over 30 years of experience in providing specialized services in the pharmaceutical and healthcare industry.
Our team is responsible for ensuring that drugs are developed and submitted for registration on time, within budget and in compliance with all scientific requirements for Quality, Safety and Efficacy.
Overall, the key features of our role are strong management skills, multidisciplinary team alignment and in-depth knowledge of Galenical and Analytical Sciences.
Our goal is to enhance and innovate in the development of outsourced pharmaceutical services in the following areas:
New Product Development
Selection of API, CDMOs, project risk assessment and regulatory affairs, scientific strategy during development stages and overall management of project milestones and resources.
Regulatory Affairs
Audit and gap analysis of dossiers, dossier compilation, eCTD and global eSubmissions.
Support during deficiency letters and life-cycle outsourcing.
QA & Compliance, Risk assessment and CMC
Manufacturing process and technology transfer involving the selection of a CMO, feasibility evaluation and scale-up to ensure efficient large-scale production.
MAH Services
Authorization Holder.
Local representative.
Management of DCP and National Phases (NP).
Clinical Studies
Selection of CMO.
Bioequivalence and biowaiver consultancy services.
Pharmacovigilance
Bibliographic searches, PV Audits.
MISSION
Pharmaceutical Innovation Services, S.L. supports pharmaceutical companies at every stage—from development and regulatory approval to post-market compliance or pharmacovigilance—ensuring long-term success.
VISION
Our goal is to provide our clients/partners with the most effective solutions to their needs, working alongside them as an integral part of their team
VALUES
TRUST
Reliable and experienced team to assist you at every stage of your project.
FLEXIBILITY
Tailor-made services, adapting to our customer’s needs.
TEAMWORK
We work closely with our clients to build a strong and fruitful partnership. We will become part of your team, working together towards a common goal.
COMMITMENT
Our team is committed to the success of your project, offering reliable technical support at every stage of the project.
QUALITY
We carry out our work to meet the highest quality standards.
YEARS OF COMMITMENT
Who We Are
Our Team
José Javier Muruzábal (CEO, Founder)
José Javier has over 30 years of experience in pharmaceutical development (galenic and analytical work) at institutions like the Department of Pharmacy and Pharmaceutical Technology at the University of Navarra. He has built his professional career in companies such as Idifarma (now part of the Ardena Group), Chemo, Ges Genericos (now part of Ethypharm) and Medalchemy, among others.
Team members
Pharmaceutical Innovation Services counts on a multidisciplinary team of experts, some with over 30 years of experience in the pharmaceutical industry, in areas such as R&D including Galenical Development, Analytical Development, Regulatory affairs, Manufacturing, Quality Control, Quality Assurance, Technical Direction (Qualified Person), Toxicology, Pharmacovigilance and Clinical Studies, among others.
