Owing to prosperous economy, New Zealand is considered as a flourishing market for Pharmaceuticals. Manufacturers willing to distribute and market their medicinal products in New Zealand must get an approval from New Zealand Medicines and Medical Devices Safety Authority - MEDSAFE. The overarching regulations for medicinal products might become tough to decode for new market-entrants and Regulatory support from an expert may be required to devise market strategy.
Freyr offers diversified Regulatory support which includes assistance in Regulatory Intelligence and market access strategy. Freyr ensures compliant dossier compilation and submissions in line with current MEDSAFE regulations. Our post-approval services are proved to be beneficial with expert and attentive tracking in place.
- Regulatory road map for registration of products in New Zealand
- Registration of New Medicine Applications (including High, Intermediate and Lower-Risk) and New Related Product Applications (NRPA)
- Support in Abbreviated New Medicine Applications, Provisional Consent Applications, renewal of provisional consent, conversion of provisional to full consent and priority assessment of NMAs
- Evaluation of the product source data from R&D and manufacturing site (executed data)
- Regulatory consultation during the development of the medicinal products
- Designing of specifications for Active Pharmaceutical Ingredient (API), finished product & intermediates
- Consultation on limits for impurities including genotoxic & elemental
- Designing of protocols (Stability, Analytical Method Validation, Exhibit Batch, Process Validation)
- Act as Qualified Person (QP) in dealing with Pharmacovigilance (PV), if required and as a local contact person to interact with HA
- Compilation and submission of the dossiers to health authority in NeeS/CTD/eCTD format (paper and CD/ DVD) in line with the MEDSAFE specific requirements
- Extension of EU/Australia dossier to New Zealand – conducting gap analysis, remediation plan, compilation and submissions of dossiers as per MEDSAFE Regulatory requirements
- Change control evaluation and compliance activities
- Assisting with Regulatory strategy and compilation for Changed Medicine Notifications (CMN), Self-Assessable Changes (SACN) and Changed Related Product Notification (CRPN)
- Support during MEDSAFE queries with strategy, preparation and submission of response document