REGULATED MARKETS

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Abbreviated New Drug Application (ANDA)

Abbreviated New Drug Submission (ANDS) for Health Canada.

Marketing Authorization Application (MAA) to Europe via CP /NP/MRP/DCP.

Marketing Authorization Application (MAA) for Australia and New Zealand.

Authoring the Module 1 (Administrative and Prescribing Information), Module 2 CTD summaries (Including clinical and non-clinical along with expert signature), Module 3 Quality, module 4 non-clinical study reports and Modules 5 Clinical study reports. 

RGI will be responsible for Booking DCP, MRP and CP slots for submission of your MAA, guidance on Fee requirement, preparation of Readability Tests or Bridging Reports and translations.

RGI provides assistance in setting up of local office in EU, arrangement of QP person, EU Agent and QPPV person, batch release and testing site in EU along specifically in Malta, Hungary, and Portugal.

Prepare regulatory pathways for switching legal status in EU with focus on regulatory legal status nationally, renewal dossier, duplicate dossier, Transfer of Marketing Authorization. 

RGI provides support to Act as Marketing Authorization Holder on behalf of the Client

RGI provides Local agent for US submission at very competitive price.