Regulatory Support in USA
Text Box: SIL’s regulatory associates in the US in tandem with our Indian associates specialize in providing the following services: Agent Representation Original Applications: INDs, NDAs, ANDAs, DMFs SIL possess the capability to file the above in eCTD format (preferred by the FDA) Amendments and Supplements including Changes Being Effected, Annual Reports, Quarterly Reports Responses to Pre Approval Inspections, 483s All other regulatory activities This part of our website is currently undergoing an upgrade to encompass the entire gamut of our regulatory services. However, feel free to contact us with your questions. Text Box: Text Box: Contact Us Text Box: About Us Text Box: Home Text Box: Our Services ►Regulatory

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