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HOME SERVICES DRUG DEV. CLINICAL TRIALS REGULATORY CASE HISTORY CONTACT

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 Intro 8

                    

ISO 2008

Dev 5  Drug Development

 

CMC / Non-clinical

During a New Drug Early Development, the primary goal is to develop and finalize the Chemistry/Manufacturing/Control documentation, determine if the new compound is safe for initial use in humans and if it shows pharmacological activity that justifies Commercial Development. Our goal is to help our clients make effective and fast Drug Development decisions. We can assist you with:

  • Chemical-Pharmaceutical Development (e.g. Chemical Synthesis/ Analytical / Formulation Development) 
  • Pharmaco-Toxicological Development

Clinical

First goal of our drug development support is to help you to successfully manage the transition from non-clinical to Phase I clinical studies (bioavailability, pharmacokinetics, safety) and provide direct control and monitoring, through our internal CRO service, with specific focus on Early Stage Clinical Development.
We can design and execute Clinical trials for Phase II in order to get some preliminary data on the activity and effectiveness (Proof of Concept) of your product, short-term side effects and risks associated with your drug.
Pharmacovigilance service is also provided.
We can both advise and execute Clinical Trial management and Monitoring through all clinical phases of Development.

 

Regulatory Affairs

Regulatory plays a critical role in Drug Development.
Costs of development refers to time and money. The cost in time can be significant if the development program is insufficient to satisfy regulatory needs. Often, companies experience negative ramifications losing time and money as processes have to be repeated because of inadequate regulatory strategy or the poor quality of the job developed.

 

 

 

We can support you in all Regulatory activities.