integrated drug development
drug product development
regulatory affairs team
regulatory strategy & support services
clinical development consultants
Integrated Drug Development
Drug Product Development
Regulatory Affairs Team
Clinical Development Consultants
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Milestones Winter 2011
Advancements being made in genomics, proteomics, and systems biology are transforming the drug discovery and development process and facilitating our understanding of the molecular underpinnings of disease.
Milestones Fall 2010
This summer marked a new milestone for Aptuit as we announced finalization of the agreement to acquire operations at GSK’s Medicines Research Centre(MRC) in Verona, Italy on July 1st, 2010. Since Aptuit’s inception, we have worked to build a world-class, integrated development organization, and this acquisition strengthens our offering in key areas.
Milestones Winter 2009/10
The financial and productivity challenges facing the pharmaceutical industry call for a shift away from the traditional, fully-integrated pharmaceutical company toward collaborations that have mutual and measurable benefits for each party.
Milestones Fall 2009
In today’s challenging drug development environment, biopharmaceutical companies are seeking new paradigms to help them develop innovative therapies that are both time efficient and cost effective.
Milestones Summer 2009
Innovation is a word used liberally in the biotechnology and pharmaceutical sectors, yet we are seeing a new variation on the notion of innovation given both the current global economic pressures and the evolving needs of the industry and those we serve.
Milestones Winter 2008/9
This edition of Aptuit’s Milestones Newsletter explores the role of the qualified person in clinical trials in the EU, electronic solutions and submission, experimental screening methods to address polymorphism, and provides update on Aptuit’s joint venture in India, Aptuit Laurus.
Milestones Fall 2008
In this fourth edition of Aptuit's Milestones newsletter, Stephen Byrn, Ph.D., addresses the challenges associated with FDA’s Critical Path Initiative and Eyal Barash describes the patent implications of new chemical entities and amorphous states. Technologies, facilities, and expertise within Aptuit's business units are also explored.
Milestones Summer 2008
In this third edition of Milestones read about the art of working with a VC backed company and Kunal Khattar, Executive Director, Aptuit Laurus, explores the current state of the Indian marketplace and partnering with a CRO in this emerging market.
Milestones Summer 2007
In this second edition of Milestones read about the shifting arena of drug development, the critical role of consulting, getting the right form first time and much much more.
In the inaugural edition of Milestones, read about the changing dynamic of the drug development industry, service offerings at various Aptuit facilities around the world, Aptuit's recent acquisition of EaglePicher Pharmaceutical's API business, and much more.
Peter Gaskin, “
Latest EU Guidelines For Biosimilars Dissected
Pharmaceutical Technology Europre
Volume 22, Issue 8, August 2010
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James A. Rogers, Matthew M. Riggs, Monte Coffiner, William R. Gillespie, Robert Burford et al., publish poster reviewing “Clinical Trial Simulation to Compare Adaptive and Fixed Designs for a Phase 3 Clinical Trial of Nacystelyn®,” at American Conference on Pharmacometrics, Mashantucket, CT, October 4–7, 2009.
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Peter Gaskin, et al., Tyrosinemia produced by 2-(2-nitro-4-triflouromethylbenzoyl)-cyclohexane -1,3-dione (NTBC) in experimental animals and its relationship to corneal injury Toxicol Appl Pharmacol. 2006
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