We deliver precise pharma regulatory, quality and pharmacovigilance services that are valuable, experiential and prominent.
Regulatory Affairs
Streamline the global regulatory submission processes from product development and registration to commercialization while ensuring compliance.
Quality, GMP & GxP Audits
Upholding the highest standards of quality compliance through 6 systems audits, pre-health authorities assessment audits and vendor audits.
Labeling & Artwork
Simplify global regulatory submission labeling and commercial labeling process for package insert, leaflets, structured product labeling (spl) and labels.
eCTD Publishing and Submission
Optimize global regulatory electronic submission in eCTD, NeeS and pCTD format from pdf processing to secure dispatch and archival of submission.
Medical Writing & Pharmacovigilance
Experience seamless medical writing and pharmacovigilance operations with advanced PV database systems and expert QPPV services.
Associate Regulatory Services
Enhance compliance for USFDA firm registrations, correspondences/communication, language translation and toxicologist (PDE/OEL) services.
NextGen eCTD
NextGen eCTD software is a robust, fully compliant, web-based software to create, manage, compile, publish, review, validate and archive the dossier in eCTD format for all eCTD accepting countries i.e. USA, EU, UK, Canada, Australia, South Africa, GCC, Jordan, Thailand, Switzerland and ECOWAS with Regulatory (Regional and ICH) specifications, validation, and compliance.
NextGen SPL
NextGen SPL software is a robust, fully compliant, web-based software to create, manage, generate, review, and archive the SPLR4 in XML format for the USA in PLR (Physician Labeling Rule)/Non-PLR format for OTC, Rx and Cosmetic Product with maximum COL (Content of Labeling), PDP (Principle Display Panel), DLD (Drug Listing Data Element) validation and compliance as per the current and proposed SPL HL7 specifications and guidance.
NextGen PDF Plugin
NextGen PDF Toolbox is an advanced productivity plug-in/add-on for Adobe Acrobat that is designed specifically for pharmaceuticals and life sciences industry to automate and expedite PDF documents processing (manual tasks to automation i.e. bookmarking, hyperlinking, ToC generation, page numbering, scale PDF along with batch operations function for eCTD/NeeS Publishing activities as per the Global Health Authorities requirements).
NextGen eDQR
NextGen eDQR is a web-based software that allows you to create, author, review, track (the progress of each document) and approve the documents for regulatory submissions in CTD, eCTD, ACTD and Country Specific Health Authorities requirements with Lifecycle Management – from document creation and until post submission archival of documents in repository.
NextGen eLN
NextGen eLN (Electronic Lab Notebook) is a web-based, digitize versions of paper notebooks, used to collect and organize R&D and ARD Laboratory data for the entire product lifecycle (start from project documentation and acquisition to sequence design, sample management, process management, and reporting by reducing noncompliance and effectively improve data. quality and productivity).
NextGen Ticket Tracker
NextGen Ticket Tracker is a unified software tool that helps clients to resolve software issues by streamlining the resolution process. The elements they handle, called tickets, provide context about the issues, including details, categories, and any relevant tags. This will allow to access to a centralized repository for change implementation management with effective work-flow to notify stakeholders for tasks assignment and status.