Atheln, Inc.
Customized pharma and biotech consulting across development, manufacturing, clinical, and commercial stages.
Atheln provides customized strategic and operational consulting across product development, CMC, nonclinical, clinical, regulatory, and commercial services for pharma, biotech, and medtech clients.
Phases
Indications / Therapeutic Areas
Services
Modalities
About this organization
Atheln is a consulting firm that develops customized, phase-appropriate, and integrated solutions for biopharma, biotech, and medtech clients. The company functions as an integrated part of development, commercial, or management teams, covering one or more competencies, supplementing competency gaps, or serving as an outsourced development partner.
Services Offered
- Product Development Strategy & Plans
- Chemistry, Manufacturing & Controls (CMC) — including oligonucleotides, small molecules, biologics, and drug-device combination products
- Nonclinical — preclinical development and testing
- Clinical — clinical trial support and operations
- Regulatory Affairs — FDA, EMA, PMDA, NMPA, and other regulatory submissions and strategy
- Quality Assurance & Compliance — cGMP, regulatory compliance, quality systems
- Project Management
- Market Research & Analysis/Forecasting
- Commercial/Product Strategy & Plans
- Reimbursement & Market Access
- Business Development
Team
Atheln has over 100 industry-seasoned experts with 20–40 years of global strategic and operational experience. The team includes specialists in oligonucleotides, medical devices, formulation development, biologics, analytical chemistry, and small-molecule development, with prior leadership roles at major pharmaceutical and device companies including Allergan, Bristol-Myers Squibb, Johnson & Johnson, Merck, and others.
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