Welcome to SEQ Regulatory Services, your partner for comprehensive Regulatory Affairs Management. We specialize in defining, managing, and implementing entire regulatory projects, offering tailored strategies, submission management, and successful regulatory approvals.
Efficient Regulatory Strategy: SEQ assists in reducing your ‘time-to-market’ by designing practical regulatory strategies that align with individual client needs. Our experts provide advice on requirements, offer opinions for regulatory submissions/approvals, and perform benefit/risk analysis for regulatory compliance options.
Submission Management Expertise: Our associates bring extensive experience to the pre-submission preparation, submission, and lifecycle management of EU Marketing Authorizations. We conduct full technical and regulatory due diligence on Product Dossiers, utilizing the advanced Submission Management System (docuBridge) for eCTD and lifecycle management. This includes National and European (CP, DCP, MRP) procedures, covering renewals, variations, and other post-approval maintenance activities.
Diverse Regulatory Achievements: SEQ has successfully managed regulatory projects across diverse therapeutic areas and the full range of dosage forms, including capsules, tablets, injections, infusions, topicals, eye drops, and more. Our achievements encompass Prescription Only Medicines (POM), Over the Counter (OTC), General Sale (GSL), Herbal products, Food supplements, and CE Marking. With over 1000 product approvals through National, Mutual Recognition (MR), and Decentralized (DC) procedures, SEQ has a proven track record of regulatory success.
For tailored regulatory solutions and more information, please contact us at enquiries@nerin.co.im.
Feel free to let me know if you have any further requests or adjustments!
