Welcome To
ALLADVICE Regulatory Consultants
Working together for
innovation in medicines
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We have REAL EXPERTISE IN ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPs).
ALLADVICE is a Regulatory Affairs Consultancy
ALLADVICE is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs) for human use, across all phases of the development, from non-clinical to post-marketing, to comply with regulatory requirements.
We work together with our clients to address key strategic regulatory challenges. Our scientific expertise covers manufacturing, non-clinical and clinical. With our support, you can cut the time and associated cost it takes to get your products to market.
Our experts are continously involved in regulatory processes with Regulatory Agencies in Europe (i.e. EMA, National Competent Authorities), US, Canada, etc.
The advice you get from ALLADVICE is from REAL experts in the industry and former regulators who have been involved in shaping today’s regulatory environment.
About Us
Alladvice Regulatory CONSULTANTS Management Team
MARIA REVIRIEGO - Pharmacy, Organic Chemistry, MSC and MBA degrees.
Ex-regulator at the Medicine and Healthcare products Regulatory Agency (MHRA) in the UK as a Pharmaceutical Assessor of registration dossiers.
More than 20 years’ professional experience across Europe mainly in Regulatory Affairs and Product Lifecycle Management of Human Medicinal Products in different biopharmaceutical companies and business models.
She worked as Regulatory Affairs Head in TiGenix (currently Takeda) where among other projects with ATMP, she was actively involved in the successfully approval of the European Marketing Authorization of Alofisel (first authorization for an allogeneic cell therapy product in Europe).
Since April 2019 she established herself as an independent consultant and has collaborated with Biopharmaceutical Companies and Public institutions in the field of ATMPs.
Lecturer in Pharmaceutical Industry Masters.
CONCEPCION TORREJON - Pharmacy, MSC and MBA degrees.
More than 11 years’ professional experience across Europe mainly in Regulatory Affairs within the pharmaceutical industry including the multinational Takeda in London (UK).
She worked in Regulatory Affairs in TiGenix (currently Takeda) where among other projects with ATMPs, she was involved in the successfully approval of the European Marketing Authorization of Alofisel (first authorization for an allogeneic cell therapy product in Europe).
She has collaborated with Public institutions in the field of ATMPs and also with the Pharmacovigilance department at the Spanish Agency of Medicines and Medical Devices (AEMPS).
Academic research experience in pharmacy.
OUR TEAM OF EXPERTS PROVIDES YOU WITH:
Regulatory Roadmaps
Scientific Advice
Clinical trials
Regulatory Tools
Dossier writing
Publishing
Others
Thanks to our trajectory and experience, we belong to recognized associations within the pharmaceutical sector.
We keep up to date on knowledge both directly related to advanced therapy and regulatory affairs.
AEFI
TOPRA
ASEBIO
SETGyC