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Regulatory Compliance Initiatives, Inc.is a globally recognized company.
We have the pleasure to help clients in nearly 40 countries, including:

 
England    Finland    New Zealand    Ireland    Slovenia    Australia    Scotland    Czech Republic    Mexico    Wales    Hungary    USA    France    Jordan    Canada    Germany    Israel    Spain    Italy    India    Haiti    Switzerland    China    Colombia    Norway    Korea    Brazil    Sweden    Taiwan    Peru    Belgium    Greece    Russia    The Netherlands    Monaco    Japan    Denmark    Chile    South Africa
 
 
Regulatory Compliance Initiatives, Inc. (RCI) is capable of helping your company, in whichever country you are located or wherever you have interests and needs. RCI has a long-standing and successful record of providing individualized support to our clients which will improve your chances of acheiving your project goals when dealing with the FDA. Whether it is the establishment of new quality systems, supporting an existing quality or regulatory system, final assembly of an electronic common technical document (eCTD), or responding to questions from the FDA, we maximize your opportunity for success.

We regularly represent clients at critical meetings with the FDA. With our expert strategic advice and high-quality submissions, you will have access to the widest market in the shortest time. Our knowledge and global contacts help us expedite products through clinical trials to market. We are well-versed in new chemical and biological registrations, the development of new medicines containing established active ingredients, generic submissions and post-approval activities. For smaller organizations, we often serve as virtual quality and regulatory departments, providing expertise as required while avoiding the expense of full-time staff.

  We have completed hundreds of eCTD and CTD regulatory submissions in the following areas:
   

 

Electronic Common Technical Document (eCTD) Common Technical Document (CTD)

 

    IND  
    NDA  
    ANDA  
    DMF  
    Site Registration    
    Product Listings    

 

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