REGFILE. Specialist consultants in pharma regulatory affairs , medical & regulatory writing, regulatory CMC and eCTD publishing.

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Let's file!


Let us take your product from ideas and data to an actual application. Let us collect, write down and compile your data by the regulatory book, and then take it through the necessary regulatory procedures. Let's get your product to the patients.
Regulatory affairs and eCTD writing and publishing

REGULATORY PROCEDURES

We handle regulatory procedures, both new applications and variations, and create and publish eCTD.  If you prefer, we are happy to act as your entire regulatory department.

meical writing regulatory writing

WRITE AND COMPILE

We write and compile the documentation for regulatory applications for medicines.  The pharmaceutical, preclinical and clinical documentation as well as pharmacovigilance documentation, product information and other administrative documentation.

perfect team

PERFECT TEAM

Our small but well-chosen group of consultants have extensive experience within their respective areas, from both the pharmaceutical industry and the Swedish Medical Products Agency and keep ourselves constantly updated.

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RegFile AB
Eklundshovsvägen 1G, 752 37 Uppsala, Sweden 

info@regfile.se

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