Nascent Pharma Consulting - Our Services
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, NDAs, MAA, ANDS
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
- Other Post-approval Variations and Renewal submissions
Regulatory Operations
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
Submission Publishing
- eCTD support for major markets (US, Europe, Canada, Australia, Switzerland, South Africa, GCC and Thailand)
- ACTD (ASEAN Common Technical Dossier)
- Health Canada REP, SPM, FDA SPLs (Lot Distribution Reports, Establishment Registrations, Drug Listings, and other Annual requirements)
- eCTD Dossier Validation and Gateway Upload and technical support
Clinical Study Report Publishing
- Formatting, publishing, and content (CSR) assembly to ICH E3 requirements
- Publishing compliance review
- Case Report Form publishing
- Submission Dispatch Management including electronic gateways, CDs and Prints.
Insourcing
Insourcing a contingent workforce allows a pharmaceutical company to scale projects up or down quickly as needed—all without affecting the headcount of the core staff.
We ensure that staff working on your new projects have expertise in current business practices and a greater understanding of data confidentiality.
Get in touch with us to learn more about Insourcing and how we may assist.