Alladvice Regulatory Consultants

Logo ALLADVICE REGULATORY CONSULTANTS SL

Contact information

Alladvice Regulatory Consultants
Conchi Torrejon, Co-founder
Albadalejo 46 4h
Madrid
Madrid
+34 639 111 925 ; +34 656 659 636
Areas of activities
  • Professional services
    • Consultancy
Commissions

MISSION

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.

VISION

ALLADVICE strives to be the premier provider of regulatory advice to biopharmaceutical companies for the development and registration of innovative medicines as ATMPs.

OUR VALUES

  • INTEGRITY.
  • QUALITY.
  • COMMITMENT.
  • FLEXIBILITY.
  • PASSION.

 

Products and services

Regulatory strategy and submissions

  • Regulatory Strategy and Roadmaps
    • Product development planning and execution
    • Long-term project management
    • Regulatory pathway
    • Gap analysis
    • Due diligence: inlicence and outlicence
  • Regulatory Preparation & Submissions
    • Clinical Trial Applications (INDs, CTAs, CTNs, etc.)
    • IMPDs, IBs
    • MAA, NDA / BLA
    • DMF (US) and ASMF (EU)
  • Regulatory Agency Interaction
    • EMA and National Scientific Advice procedures
    • ITF meetings
    • EMA/HTA parallel consultation
    • PRIME/BTD/RMAT
    • ODD (Orphan Drug Designation)
    • PIP/PSP
  • Regulatory Lifecycle Management
    • Strategy and implementation
    • Post-approval lifecycle management including variations, renewals, PSURs, notifications, etc
  • Other regulatory activities
    • SME status
    • ODD
    • ATMP classification and certification

CMC Regulatory Activities

  • Agency meeting preparation and attendance
  • Revision/writing CMC documents
  • DMF/ASMF revision/writing
  • Responses to Agency Questions
  • Post-approval maintenance
  • 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

Non-clinical and Clinical

  • Strategic development
  • Revision/writing non-clinical and clinical documents
  • Review clinical protocols:
    • FIH, Exploratory and Confirmatory
  • Agency meetings:
    • Preparation and attendance
    • Draft/review non-clinical and clinical data, defend and review company position
Areas of interest for future collaborations

Participate in consortia that are formed in the context of European grants / funds such as Horizon Europe, Missions Program, etc.