We provide expert guidance on the creation, planning, and execution of drug development programmes from discovery to market authorisation. Our drug development consultancy services include CMC, non-clinical, clinical pharmacology and development, biostatistics, and regulatory affairs across a wide variety of therapeutic areas.
With our independent position, we can design an optimal programme, focusing on risk assessment and mitigation, ultimately saving time and money while meeting project milestones. All our consultancy services can be contracted as a package or as a stand-alone service, offering flexibility to meet your needs.
For a more detailed overview of the services that we offer, please refer to Drug Development Consultancy - Venn and Drug Development Consulting - CRS.
We provide expert consulting services for all aspects and stages of CMC in pharmaceutical and biological product development, including drug-device combinations. Our support extends to small, midsize, and large (bio)pharma companies.
Our CMC experts can seamlessly integrate with your in-house team, assist in selecting and managing contract and development manufacturers (CDMO), and participate in multi-disciplinary development teams to advance your product, process, and method development.
Our experienced non-clinical team supports all stages of development, from lead candidate selection to market approval. We integrate seamlessly with in-house teams and contribute to multi-disciplinary groups to accelerate timelines and ensure successful outcomes.
Our team of clinical experts support biotech and pharma companies with non-compartmental (NCA) pharmacokinetics (PK), pharmacodynamics (PD), biomarker, and anti-drug antibodies (ADA) analyses, along with translational modelling & simulation and clinical pharmacology consultancy, covering all Phase I and Phase II/III studies. Collaborating within multi-disciplinary teams, they advance early clinical development with strategic insight and guidance to ensure a safe and effective transition from preclinical to all clinical phases.
Our biostatistics consulting group offers comprehensive support for clinical study protocols, including study design, sample size calculation, and defining objectives and endpoints (including estimands).
We provide expertise in complex statistical methodology, innovative designs, handling missing data, regulatory guidance for strategic development and support at meetings with regulators. We also offer extensive support for Data Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) meetings, including support in charter development and provision of unblinded statistician.
We offer specialised regulatory consulting services spanning early drug development through to market authorisation. Our expert consultants act as an extension of your team, crafting customised regulatory strategies and ensuring their efficient execution.
We provide the support you need to navigate complex regulations and achieve successful outcomes.
For a more detailed overview of the services that we offer, please refer to Regulatory Affairs Consultancy - Venn Life Sciences and Regulatory Consulting - CRS for further information.
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