How We Help
At Consilienta, we support clients across the biopharma spectrum, from agile startups to established global players, with tailored regulatory and development expertise. Our services are designed to accelerate innovation, streamline global product development, and ensure a smooth, compliant path from concept to approval. From embedded regulatory functions to due diligence and training, our services are designed to integrate seamlessly with your team and drive your product forward with confidence.
Drug Development
Advice on Manufacturing, Nonclinical and Clinical Development Plans, Translational Liaison Service.
Click for detailsRegulatory Strategy
Strategy and Planning, Orphan and Pediatric, Due Diligence, Training and Coaching, Embedded Regulatory Function.
Click for detailsAgency Interactions
Scientific and Regulatory Support, Scientific Advice, Dossier Preparation, EU Regulatory Agent Services, SME services.
Click for detailsClassification and Designation
Product Classification, Expedited Development Programs, New Active Substance Assessment.
Click for detailsSafety
Microbial and Viral Safety, Material of Animal and Human Origin, GMO and Risk Assessments.
Click for detailsInnovative Medicines
ATMPs, Biologics/Synthetics, Innovative Small Molecules, Combination Products, Individualized Therapies.
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