Who We Are ?
We are a specialized team dedicated to helping pharmaceutical, biotechnology companies navigate the complex world of global regulatory requirements. With expertise in regulatory publishing, eCTD submissions, dossier management, and compliance support, we ensure that your products meet all necessary regulatory standards allowing you to focus on innovation and patient care. Our goal is to act as your regulatory partner, streamlining the submission process and ensuring faster approvals across multiple regions including US FDA, EMA, MHRA, Health Canada, TGA authorities.
What We Do ?
1. Regulatory Submissions
We provide end-to-end regulatory submission support tailored to your market strategy:
- eCTD (Electronic Common Technical Document) Submissions
- Compilation, publishing, and lifecycle management of eCTD dossiers.
- Compliance checks against regional specifications (FDA, EMA, PMDA, TGA).
- NeeS / Paper to eCTD Conversion
- Transition legacy submissions to eCTD formats.
- Clinical & Non-Clinical Submissions
- IND, NDA, ANDA, DMF, IMPD, MAAs, BLAs.
- Post-Approval Lifecycle Management
- Variations, amendments, renewals, supplements, and annual reports.
- Global Regulatory Filing Support
- Multi-country dossier formatting and submission support for emerging markets.
2. Publishing Services
We ensure your regulatory documents are submission-ready with robust publishing and QC processes:
- Document Formatting & Standardization
- Conversion to agency-compliant formats (Word, PDF, XML).
- Bookmarking, hyperlinking, TOC creation, and metadata optimization.
- Validation & Quality Check
- ICH and regional compliance verification.
- Technical validation before submission to prevent rejection.
- Dossier Management
- Compilation, publishing, and archival of CTD / eCTD dossiers.
- Secure Transmission
- Agency gateway submission via FDA ESG, EMA CESP, or country-specific portals.
3. Strategic Consulting & Support
- Regulatory Roadmap Development – early planning of submission strategy.
- Gap Analysis & Compliance Checks – ensuring documents meet ICH/agency standards.
- Training & Knowledge Transfer – helping your in-house teams adopt regulatory best practices.
- Project Management & Timelines – delivering on time, every time.
Why Choose Us?
- Expertise Across Regions – FDA, EMA, MHRA, PMDA, TGA.
- 100% Compliance-Driven Approach – ICH guidelines, regional modules, and industry standards.
- Scalable Solutions – from small biotech submissions to global pharma lifecycle management.
- End-to-End Partnership – from pre-submission planning to post-approval support.
- Cost-Effective & Efficient – reduced rejection risks, faster approvals, and optimized processes.