Regulatory operations
Support with regulatory project management
Our project managers can take on regulatory as well as cross-functional projects and deliver high quality submissions.
Our project managers can take on regulatory as well as cross-functional projects and deliver high quality submissions.
Skilled regulatory project managers are critical to the success of global projects. Planning and executing high-quality submissions across multiple markets to meet project timelines ensures that the products reach the market.
Arex Advisor have an experienced team of regulatory project managers with a wide range of specialities, including global regulatory affairs.
The project managers can be involved in:
– Strategic decisions for the lifecycle management of products
– Preparing and delivering on regulatory plans
– Authoring documents
– Acting as the contact point for regulatory authorities
Our team has experience from a range of global regulatory functions, working with different types of products, at all stages of the product lifecycle.
We can help with short- and long-term projects, integrating into the client’s team.
We are flexible and can adapt to the client’s needs, including providing fixed rate projects where we guarantee a set number of full time equivalents (FTEs).
Lifecycle management
Regulatory documentation management
Product information services
Erik Hedner
Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.