Solve can help our clients to navigate the complex landscape of pharmaceutical regulatory affairs. With in depth knowledge of the regulations in markets globally, our experts can help to craft strategies which help support product registration in a pragmatic, and efficient manner.

By getting to know our partners and their goals, we strive to deliver tailored strategies which are based on current international guidance and standards, contemporary precedence and local regulatory intelligence.

With over 100 years of combined regulatory expertise, this is our bread and butter - but there are no cookie cutters here!

With intimate knowledge of the electronic Common Technical Document (eCTD) structure and individual country requirements, our team can help to prepare high quality scientific documentation which meet with exacting regulatory standards.

Our team are well honed writing machines who can translate complex technical information into concise, well-structured scientific arguments. We make it sound easy – even though it’s not – but we love the challenge of helping our partners to convert their years of scientific effort into articulate and compelling eCTD dossiers.

What is worse than no documentation – bad documentation!

With our broad range of regulatory expertise, Solve can help our clients manage their regulatory submissions from end to end!

Our regulatory operations staff have extensive experience of preparing submissions for all markets globally and can help our clients to understand the mysterious world of regulatory “publishing” to ensure that their submissions don’t fall at the final hurdle.

Our experts can provide advice on document management tools, publishing software, document storage and maintenance to assist them in managing their product effectively and in line with current regulatory requirements.  

Let the experienced team at Solve help you achieve successful outcomes in your interactions with global regulatory bodies. When the stakes are often high, allow us to hold your hand through what can often be a daunting process.

Having worked with all of the major regulatory bodies around the world over the years (such as US FDA, EMA, TGA, PMDA and NMPA) we can help you to navigate the cultural and regulatory nuances of each jurisdiction.

Solve are well versed in the administrative steps associated with the set-up of regulatory agency meetings. We can also help you to position your product for success through the development of high-quality briefing documents with targeted strategic questions.

We can help your team prepare for the meeting through the aid of role playing, scenario planning and mock meetings, and will be there to answer your questions along the way

“Do I need to wear a tie? Will they answer a question that was not on our list? How should I address them?” Don’t worry we’ve heard them all before.

Solve can assist investors and financial institutions by undertaking regulatory due diligence on assets in the pharmaceutical and biotech industry. Prior to making investment decisions, Solve can assist in the review of regulatory and project documentation to identify potential risks.

With an in depth understanding of development processes, timelines and costs Solve can assist in assessing the feasibility of product development and registration plans and any potential pitfalls that may not have been identified. What can be a quick and relatively low cost activity can assist in de-risking major investments allowing you to enter into a relationship with your eyes wide open.

Solve are able to manage all of your regulatory activities from go to woe!

Acting as your in house regulatory team we can support all regulatory activities from early stage nonclinical development, through to registration and post approval maintenance.

We can act as your local agent in Australia and New Zealand, managing all of your ongoing obligations with TGA and Medsafe. We can support future product lifecycle such as ongoing changes and even assist with commercial expansion into new indications or markets. Let us take away the strain on your internal resources and know that your products are in good hands.