Regulatory Publishing and Submission Services
For Life Sciences

The key components of publishing for pharmaceutical application dossier submission include understanding the regulatory requirements for publishing in country of interest, identifying the right format and key components of the document, applicable format for submission (eCTD, pCTD, NeeS etc), submission gateways (ESG etc), suitable publishing software, submission planning and trackers, quality check at each level of document and submission level publishing, submission to health authority and archiving.

Our centralized publishing and submission team has experience in publishing dossier in multiple formats, products and dosages forms across multiple countries worldwide. We have established processes and procedures to ensure high quality, right first time publishing submissions based on our experience and quality driven systems and KPIs.

The key challenges faced by pharmaceutical and biotech companies during publishing include, understanding of country specific publishing requirements and guidelines, lack of established processes, lack of experienced in house team for publishing, availability of cost effective software for publishing, shorter deadlines and time sensitive multiple submission requirements, experience in multi-country experience, among other challenges.

Pharma Wizard’s centralized regulatory intelligence team, supported by structured processes and a robust technology platform, continuously tracks new regulations, guidelines, notifications, and updates from global health authorities. Our regional teams also contribute insights through their strong networks with local trade and industry associations. All information is processed, structured, and stored in a central repository—providing actionable intelligence that supports efficient and compliant publishing and submission activities.