Firstdot Pharma, providing dossier compilation and regulatory affairs comprehensive consulting services. Firstdot Pharma acts as knowledgeable guide on regulatory affairs to Pharmaceutical companies wanting to introduce products into global markets.
First dot specializes in the area of regulatory services;
Repackaging Product Listing \ Bulk Drug Listing \ OTC Product Listing \ NDC Product Listing \ Animal Drug Listing for US market
Drug Establishment Registration (FEI) Services for US market
NDC \ NHRIC Labeler Code Request
Annual Product Listing\Blanket No Change Certification SPL
GDUFA Self Identification for US market
eCTD Service for compilation and publishing for ANDA and Drug Master File
Annual Reports & Amendments to ANDA and Drug Master File in eCTD
Lifecycle Management for SPL Submission and Product
First dot Pharma have a team of qualified and dedicated staff with rich experience of dossier compilation, labeling and compliance across global drug authorities. First dot Pharma need only a chance to be able to make the steps necessary to make an impact and establish our brand in the global market.
First dot Pharma not only do what our clients expect us to do, First dot Pharma also help them better by offering tips on managing regulatory activity effectively. Please feel free to contact First dot Pharma on details mentioned below, in case you need to utilize any of the services that First dot Pharma provides.
Hope to hear from you soon and waiting to get a chance to serve your company.
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