The team at MTA can support your scientific advice requests, prepare and submit dossiers (OTC and prescription) and listings (complementary medicines).
With significant experience in preparing and reviewing CTDs, MTA provides dossier gap analysis and remedial action plans. MTA can guide you with registering products in Australia, New Zealand, Singapore and Canada.
If you’re looking to market your products in Australia and New Zealand, MTA can work with your regulatory team to set up regulatory strategies and assist with firming up distribution channels.
MTA provides technical regulatory support with filing through eCTDs, paper, reviewing CMC sections and DMFs as well as writing expert reports.
MTA also provides these additional services:
• Represent clients at pre-registration meetings
• Negotiate with regulatory agencies to resolve restrictions and expand label claims
• Provide assistance with interpreting regulatory legislation
• Respond to requests from regulatory authorities on behalf of clients
• Review artwork and promotional material for consistency with approved claims
• Prepare and submit product information/consumer medicine information
• Undertake regulatory compliance activities to maintain clients’ portfolio in various markets
• Track progress on product registrations against milestone dates