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Quantum Regulatory Solutions
Kalamazoo, Michigan, United States
- Ownership
- Private
- Employees
- ~30
- Development stage
- Other
01
Overview
Quantum Regulatory Solutions is a boutique regulatory consulting firm founded in 2023. It provides comprehensive regulatory support for pharmaceutical and biotech companies at all stages of drug development—from pre-clinical through post-marketing. The team has filed over 140 marketing authorizations and supported the launch of more than 100 products in the US. Their services include strategy development, agency liaison/meeting support, CMC guidance, medical writing, labeling/ad-promo review, project management and more[1][2][4][5].
- Therapeutic areas
- Rare DiseasesNeurologyPsychiatryInfectious DiseasesDermatologyHematologyEndocrinologyOncologyOtherImmunologyCardiovascular
- Modalities
- Small moleculeBiologicCell therapyGene therapyCombination productDevice
- Industry
- Consulting
02
Partnerships
No major pharma or biotech partnerships disclosed; as a consultancy they work with multiple client companies ranging from startups to multinationals
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