- reguscript@gmail.com
- +917794807940
- GSTIN: 36CPHPM4031F1Z3
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Regulatory Affairs
Your trusted partner in global Regulatory Affairs compliance and CMC Excellence
Reguscript provides comprehensive Regulatory Affairs services to support pharmaceutical companies throughout the entire product lifecycle. Our expertise spans strategic planning, technical execution, and ongoing regulatory guidance, covering critical areas such as Due Diligence, Gap Analysis, and New Product Authorizations.
We deliver tailored, end-to-end solutions that streamline market entry, minimize approval timelines, and empower your organization to make informed decisions—driving commercial success across global markets.
Keyword Research
Explore our services
- Industries We Serve :- Reguscript provides specialized regulatory solutions across multiple industries, ensuring compliance, efficiency and innovation for your products and services.
- Pharmaceuticals / Medicinal Products :- We manage all stages of pharmaceutical products, including development, dossier preparation, gap analysis, submissions, and post-approval lifecycle management.
- Herbal, Food & Nutraceuticals :- We support herbal supplements, functional foods, and nutraceuticals to ensure product compliance, label assessment, claims review, classification, registration, and market continuity in line with global regulatory requirements.
Our Services
Our Services
Regulatory Strategy & Consultation
- Regulatory pathway assessment
- Product classification & regulatory intelligence
- Gap analysis and risk evaluation
- Country-specific regulatory guidance
Dossier Preparation & Submission
- Preparation of CTD / ACTD / eCTD dossiers
- Compilation, formatting, and publishing
- Module-wise document development
- Submission to national and international regulatory agencies
Regulatory Filings & Approvals
- New Drug Applications (NDA) / Abbreviated NDA (ANDA)
- Marketing Authorization Applications (MAA)
- IND / IMPD submissions
- Variations, renewals, and line extensions
Medical Devices Regulatory Support
- Device classification and regulatory strategy
- Technical file and CE marking support
- 510(k) submissions and PMA applications
Labelling & Artwork Compliance
- Label review and regulatory conformity
- Mock-up creation and proofing
- Global labelling updates and translation coordination
Regulatory Writing Services
- Clinical and non-clinical overviews
- Summaries and expert reports
- Responses to agency queries
- Risk management plans (RMP) and PSURs
Post-Approval & Lifecycle Management
- Regulatory variations and renewals
- Pharmacovigilance compliance support
- Periodic reporting and safety updates
- Labeling changes and ongoing compliance management