Aptuit Consulting is comprised of highly experienced scientists and regulatory experts who are dedicated to helping clients achieve the development of safe and effective medicines and devices in a cost effective and timely manner. Our consultants are based throughout the U.S. and Europe, each with successful track records in managing multiple aspects of pharmaceutical R&D.  We integrate into your team to help get your product to market by coordinating the myriad of steps within the drug development process.

Consulting

Aptuit Consulting is a global pharmaceutical, medical device and intellectual property consultancy.  Our consultants act as an extension of a client’s internal team, helping to manage drug development programs by providing expert advice and counsel.

Managing the myriad of steps in developing new medical products for regulatory approval is complex, costly, and time-consuming. Even though there are numerous providers capable of undertaking work to achieve discrete development steps, coordinating these steps within an appropriate regulatory framework requires considerable skill and experience.

Aptuit Consulting is comprised of experienced industry professionals with proven track records in managing the process of getting new medicines to market. Our seasoned consultants have broad drug development, medical device, and product defense skills covering all therapeutic areas:

  • Intellectual property defense
  • Product tampering
  • Manufacturing
  • Formulation
  • Metabolism
  • Pharmacokinetics
  • Safety Pharmacology
  • Toxicology
  • Regulatory  Strategy and Submission Services
  • Phase 1 to Phase 4 clinical program design

We subscribe to the highest ethical and business standards and are dedicated to providing unbiased advice based on training and expertise in our respective scientific disciplines. Understanding the limitations of time and funding, we offer solutions that take these factors into account. Typically, our consultants survey all service providers on your behalf and identify the best solution for your needs.

Whether your development team needs a clinical oncologist to advise on Phase I study design, a toxicologist to study a safety issue, a CMC expert to review your drug substance/drug product dossier or a whole team to cover all aspects of the development program, we can provide experienced consultants when you need them. We are a premier group that brings together, under one roof, all scientific and regulatory disciplines required for a successful drug development program, spanning API scale-up to Phase IIa proof-of-concept clinical studies.

Please visit our website at www.aptuitconsulting.com for a comprehensive look at all of our services and breadth of experience.

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