Speed To Clinic Accelerator

Accelerate preclinical‑to‑clinical transition with integrated IND enabling consulting, backed by (founded on, substantiated by, or supported by) comprehensive bioanalysis solutions and deep expertise across early drug development—including CMC, nonclinical, clinical, and regulatory affairs.

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Our Expertise

  • 100+ IND‑enabling programs supported
  • Integrated CMC and non non-clinical consulting expertise
  • In‑house bioanalysis & biomarker labs linked with data analysis
  • Seamless transition from preclinical → clinical via internal labs & Phase I operations
  • Faster execution enabled by agile governance & rapid project start‑up
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Strategic & Operational Support

Strategic Support

  • Gap analysis and definition of a streamlined pathway‑to‑clinic with Drug Development Plan as a deliverable

  • Strategic IND enabling consultancy support as an extension of your project team

  • Regulatory roadmap and health authority engagement planning

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Drug Development Support

  • CMC: Defining CMC development strategy, CDMO selection and oversight of full CMC development, GMP audit  

  • Nonclinical: Defining non-clinical development strategy, oversight of GLP studies, bioanalytical testing of toxicokinetic (TK) samples seamlessly combined with TK data analysis 

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Clinical Development

  • Clinical: Defining early clinical development strategy, human dose prediction support, first‑in‑human study design 

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Laboratory Solutions

  • Bioanalytical method development and validation 

  • Laboratory package – antidrug, antibody, and neutralizing antibody assays 

  • Lead candidate selection 

  • Lead targeting (MoA) 

  • Seamless transition (preclinical → clinical) via linked internal labs and Phase I operations 

  • Agile governance with rapid project start‑up 

  • Bioanalytical analysis 

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Why Consider hVIVO

1

 Integrated IND enabling consultancy with internal labs and Phase I operations 

2

 Agile, high‑quality delivery with proven customer loyalty 

3

 Expedited and transparent contracting 

4

 Robust bioanalytical capabilities seamlessly combined with PK/TK data analysis 

For start-ups and scale ups

For start-ups who do not have the internal resource for a PK role, we can work as an extension of your team to support rapid decision-making, fundraising milestones, and efficient PK insights with fast turnarounds.

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For Emerging & Mid-Size Biopharma

Ideal for teams needing interim or final PK/PD analyses, dose escalation support, validated NCA outputs, and consistent reporting.

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Development Stages Supported

Preclinical to First‑in‑Human

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FAQs

 Yes—our model integrates CMC and nonclinical consulting with  clinical, regulatory, and laboratory (biomarker and bioanalysis) expertise 

No—our solution also supports your first-in-human trial application in the EU (EMA), UK (MHRA) and more.

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