As a committed global regulatory service provider, Athreva can assist pharmaceutical companies to obtain timely approvals for their manufactured products from region-specific health authorities (HAs). Our curated team of Regulatory Publishing Services experts are proficient in delivering efficient and cost-effective regulatory operations which include submission management/ planning, publishing strategy, document level publishing (DLP), submission level publishing (SLP), and translating your complex data and results into formatted submission-ready documents based on ever-changing HA requirements.
With a proven expertise in eCTD, Non-eCTD (NeeS), PDF and paper submission formats for both pre-approval (original application, amendment to original application) and post approval (variations/ supplement, annual report and PSUR/ PADER) data globally, we can help you navigate through stringent HA guidelines with a suite of streamlined end-to-end regulatory publishing services.
In an ever-changing regulatory landscape, Athreva strives to stay at the forefront of paper and electronic submission requirements on a qualitative note at an affordable rate and with quick turnaround time. We provide inclusive regulatory publishing services to Pharmaceuticals, Biopharmaceuticals, Healthcare, CMO and Clinical Research industry and deal with both regulated and semi-regulated markets. Our meticulously picked Regulatory Publishing team ensures that documents are formatted using standardized industry templates with appropriate granularity and formatting consistency across the dossier, resulting in a right first time approach. As your trusted publishing partner, Athreva offers the following Regulatory Publishing services:
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