drug development programs | medical device | intellectual property defense
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drug development programs | medical device | intellectual property defense
drug development programs | medical device | intellectual property defense

Aptuit Consulting is a unique, global drug development, medical device and intellectual property consultancy, comprised of a dedicated team of highly experienced scientists and regulatory consulting experts with first-hand experience and proven track records in managing all phases of drug development. We support the biomedical industries and their investors by providing comprehensive and integrated drug development services from early development to First in Human and proof of concept studies.

Services available include support on specific needs to “fill a gap” or by serving as your complete drug development team providing an integrated approach across the following areas:

Integrated Drug Development

  • Drug development plan and timeline
  • Aptuit INDiGO and First in Human Programs
  • Virtual drug development

Nonclinical Development

  • Toxicology
  • ADME
  • Pharmacokinetics
  • Safety Pharmacology

Chemistry, Manufacturing and Controls

  • Formulation development
  • Manufacturing

Regulatory

  • Strategy, Support &
  • Submissions (ePublishing) PoC

Clinical

  • Clinical program design
  • Phase 1/First in Human to Phase 2 PoC
Take a closer look at how we are uniquely qualified and differentiate ourselves in the drug development consulting arena.
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US FDA Pregnancy and Lactation Labeling Changes Expected
Mass Biotech Council Panel Discussion
Aptuit Consulting Capabilities Overview
"Redefining the CRO"
Watch our webinar to learn more about electronic submissions to global regulatory authorities