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 life cycle 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
Lovisa Rosenquist
Arex Advisor AB
Contact us
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.