Regulatory Affairs
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
Quality
MTA can assist with a range of quality and compliance issues faced by business, with a focus around developing and optimising Quality Management Systems to meet GMP, ISO and PIC/S guidelines as well as providing support with audit preparation and response.
Key areas of expertise include:
• Regulatory audit planning and preparation
• Validation support (process, equipment and cleaning)
• Writing validation master plans, protocols and reports
• Set up and manage GMP contracts on behalf of clients
• Carry out third party audits and work with companies to close gaps
• Maintenance of off-site stability programs
• Conduct annual product reviews
• Build training systems and provide site-based GMP training
• Preparation of technical documents including SOPs and Work Instructions
• Risk assessments and mitigation plans
Product Development
MTA offers product development support from ideas to innovation. We’ve helped entrepreneurs and companies develop formulations based on innovation and gaps we see in the marketplace. We also partner with other companies to bring to our clients alternative formulations and dosage forms. MTA identifies niche areas in the market and works with clients to formulate novel products.
Our extensive industry experience provides unique capabilities to bring your new products from concept to commercialisation. By streamlining the R&D process we can bring formulated products to market faster.
Our product development process involves five key steps:
1. Ideas generation
2. Product feasibility and market analysis
3. Formulation development
4. Conducting trials and testing
5. Scale-up for manufacturing