Our Services
Regulatory Operations and Publishing
*****************************500+ sequences published, over 50000+ documents processed, and 10+ clients served***************************
Nascent publishing services offer full lifecycle management of the submission process with flexible options for report-level publishing, submission publishing, compilation, and lifecycle maintenance.
Our expert Regulatory Operations team is well-equipped with exclusive and advanced eCTD tools and plug-ins. We’re capable of tracking, executing and managing the regulatory operations activities of all submission types for our clients.
Document Publishing
- Legacy document conversion
- Formatting of Word documents for technical integrity & ease of future revisions
- Bookmarks and hyperlinks creation, Advanced PDF fixups
- Clinical Study Report (CSR) and CRF Publishing
- Anonymization & Redaction of Clinical Trial Data
Submission Publishing
- eCTD support for major markets (US, Europe, Canada, Australia, Switzerland, South Africa, GCC, Singapore and Thailand)
- ACTD (ASEAN Common Technical Dossier)
- eCTD Dossier Validation and Gateway Upload and Archival
Operations and Compliance
- SPM services for Health Canada
- SPL services for the US FDA include Establishment Registrations, Renewals, Drug Listings, Lot Distribution Reports, Drug Samples and other annual requirements
Regulatory Affairs and Compliance
We possess global Regulatory Affairs (RA) capability to deliver end-to-end solutions for your product portfolio registration and life cycle maintenance.
Utilizing our international network, we have a team of highly experienced RA professionals to offer diverse regulatory support and services related to Drug Substances and Drug Products in the very competitive landscape of pharmaceuticals.
Our expert, Regulatory Affairs professionals, are capable of tracking, executing, managing and training on the activities of all of the submission types for our clients.
Regulatory Compliance & Drug Master Files (DMFs):
- Establishment License (EL) and EL Amendments
- Assessments of Change Controls
- DMF compilation in CTD/eCTD format
- Authoring of restricted/applicant part of DMF
- Review of DMF for submission
- Type II DMF Preparation and submission
Regulatory Pre-Approval Services:
- US FDA and HC registration of dossiers: CTAs, INDs.
Regulatory Post-Approval Services:
- End-to-end life cycle management service supporting license maintenance (variations, renewals, annual reports)
- Preparation and review of labelling/mockups
- Compliance gap analysis
Optimizing Operations Through Technology Innovation
At Nascent, we deliver customized solutions to optimize regulatory data management and intelligence reporting, ensuring compliance remains the top priority. Our sophisticated tools streamline data collection, automate regulatory submissions, and enhance report generation—helping pharmaceutical companies stay compliant with evolving regulations.
Explore our solutions today and transform the way you manage regulatory data and intelligence reporting.