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

A Pharmaceutical Development, Medical Device and Intellectual Property Consultancy

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. Our drug development experts can provide fully integrated programs with first in human and proof of concept studies at either fee for service or fixed prices.

Our team of experts at Aptuit Consulting has participated in the development, submission and approval of hundreds of regulatory filings across the globe. 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 & 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 and
    Submissions (ePublishing)

Clinical

  • Clinical program design
  • Phase 1/First in Human to Phase 2 PoC

Legal

  • Intellectual property defense
  • Product tampering
  • Expert witness testifying

For further information on how we are uniquely qualified and differentiate ourselves in the drug development consulting field and to take a closer look at our offerings, please visit our staff and services page or contact us.

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US FDA Pregnancy and Lactation Labeling Changes Expected
2009 BIO International Convention
Podcasts, Presentations, Webcasts and much more!
Virtual Drug Development
Watch our webinar to learn more about electronic submissions to global regulatory authorities