CTA / NDS / SNDS / DIN Preparation & Monitoring
Medical Market Consultants
Managing the Business of Science™
Spectrum MMC has an extensive track record and experience in the preparation of various submission documents. Submission types include, but are not limited to, Clinical Trial Applications (CTAs), New Drug Submissions in CTD format (NDS), Abbreviated New Drug Submissions (ANDS), DIN applications (DINA), notifications on changes to marketed products (SNDS etc.) and Rx to OTC switches. Our strategic stewardship leveraged by our commitment to quality and attention to detail are just some of our core strengths, which contribute to the successful completion of our projects.
Drug Submissions preparations includes:
- Comprehensive analysis of the regulatory status of proposed new products and development of appropriate strategies to secure approval.
- Preparation, submission, approval and monitoring of investigational and/or premarketing approval applications for new drug products.
- Review of labelling, advertising and promotional materials for drug products to ensure compliance with applicable regulations.
- Submission summaries designed to highlight the bottom-line findings of the submission and to facilitate the reviewing process.
Experience. Service. Quality.