Preparing a regulatory submission successfully requires significant effort and attention to detail. Errors and inaccuracies can lead to costly delays that you do not want to risk.
We accelerate the regulatory submissions of medical innovations worldwide through customized, tech-enabled regulatory solutions. Our seasoned experts leverage the latest technology and automation tools to speed up the process and minimize errors in support of your goals.
Here is what our partners say:
“Flexible, supportive and do their best to meet resourcing requests!” – Medical Communications Scientist at top 10 global pharmaceutical company
“I find their quality to be high and the staff to be professional. They meet timelines and comply with sponsor processes.” – Associate Director of Drug Safety at publicly traded, global pharmaceutical company
“Excellent customer service. Diligent follow up.” – Director at global, publicly traded pharmaceutical company based in Japan
How we help our clients
We focus on strategy first, and then map an efficient and effective operational plan. By involving us as a strategic partner—as early as identification of a lead candidate through life cycle management.
We ask the right questions during front end meetings and working together, assess the right processes, tools, and resources to achieve all your goals.
An astonishing number of documents, communications, and presentations must be produced at every stage of development.
Our highly skilled and scalable team manages the transition from pre-clinical programs to clinical development, through submission and approval, to post marketing safety with rigorous and proven quality control processes.