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Atheln, Inc. vs MDx CRO

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CategoryAtheln, Inc.MDx CRO
Listed sitecrocro
SummaryAtheln provides customized strategic and operational consulting across product development, CMC, nonclinical, clinical, regulatory, and commercial services for pharma, biotech, and medtech clients.Full-service CRO for IVD manufacturers, medical device companies, and precision medicine sponsors. Offers performance studies under ISO 20916 and ISO 14155, EU MDR/IVDR and FDA regulatory support, and companion diagnostic development.
Services
  • Analytical Method Development & Validation
  • Regulatory Affairs
  • US FDA Regulatory Strategy
  • EU EMA Regulatory Strategy
  • Japan PMDA Regulatory Strategy
  • Clinical Operations
  • Medical Writing
  • Translational Research
  • China NMPA Regulatory Strategy
  • Clinical Trial Services
  • Biostatistics & Statistical Programming
  • Clinical Operations
  • Data Management & eClinical
  • Biostatistics & Statistical Programming
  • Regulatory Affairs
  • US FDA Regulatory Strategy
  • EU EMA Regulatory Strategy
  • Companion Diagnostics Development
  • Translational Research
  • Analytical Method Development & Validation
Modalities
  • Small Molecule
  • Biologics (Other)
  • Oligonucleotide
  • Peptide
  • Radiopharmaceutical
Data not yet provided.
Indications
  • Ophthalmology
  • Oncology
  • Rare Disease
LocationsData not yet provided.
  • Barcelona, Barcelona, Spain
  • Madrid, Madrid, Spain
  • London, London, United Kingdom
  • Lisbon, Lisbon, Portugal
CertificationsData not yet provided.Data not yet provided.
ReviewsReview summary appears after site-level review signal gate opens.Review summary appears after site-level review signal gate opens.