ALLADVICE REGULATORY CONSULTANTS SL
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.
Our mission and passion are to work for our clients and to combine the strength of our expertise and innovation to advance their success in preventing and curing disease.
ALLADVICE strives to be the premier provider of regulatory advice to biopharmaceutical companies for the development and registration of innovative medicines as ATMPs.
ALLADVICE brings our clients more than 20 years of experience in Regulatory Affairs. We have collaborated with Biopharmaceutical Companies and Public Institutions in the field of ATMPs working among others with Oncolytic viruses, Adeno-associated virus (AAV), Plasmids, Adenovirus (AdV), CAR-T, Mesenchymal stem cells, Bone marrow-derived hematopoietic stem cells, Adipose-derived stem cells, etc.
Our experts are continuously involved in regulatory processes with Regulatory Agencies in Europe (i.e. EMA, National Competent Authorities), US, Canada, etc.
Regulatory strategy and submissions
- Regulatory Strategy and Roadmaps
- Regulatory Preparation & Submissions: CTA, IND, IMPD, IB, MAA, NDA/BLA, DMF, ASMF, etc.
- Regulatory Agency Interaction: Scientific Advice (EMA and national), FDA meetings, ITF meetings, EMA/HTA parallel consultation, PRIME, BTD, RMAT, Orphan Drug Designation, PIP/PSP
- Regulatory Lifecycle Management
- Other regulatory activities: ATMP classification and certification, SME status
CMC, Non-clinical and Clinical
- Strategic development
- Revision/writing CMC, NC and C documents
- Review clinical protocols, FIH, Exploratory and Confirmatory
- Agency meeting preparation and attendance
- Draft/review CMC, nonclinical and clinical data, defend and review company position
CMC Technical Advisory
- Manufacturing and Quality
- Analytical Method Development/Validation
- Potency Assay strategy
- Release and Stability testing, Specifications
- Process Development and Validation, QbD
- Identification of CMO, Technology Transfer and Comparability.
Regulatory training on ATMPs