Regulatory operations

Pharmaceutical product lifecycle management

We help your improved product reach the market faster by supporting the development of your product lifecycle strategy and perform activities related to regulatory maintenance.

Maximising patient value for pharmaceuticals

Pharmaceutical lifecycle management is about maximising the value of the drug product to customers and patients.

This can include:

  • Improved formulations or packaging
  • Launches in new markets
  • Introduction of new indications
  • Improvements to efficacy, safety, or patient compliance
  • Periodic reports such as DSUR, PSUR, PBRER, PQR and annual reports

 

Why use our support with life cycle management?

Products, regulations, competition, and patient needs tend to change continuously over time. Arex Advisor have the in-house expertise to guide you from the early development phases to late post-approval stages. We can maintain your regulatory file throughout the entire product lifecycle.

More regulatory operations services

Regulatory project management
Regulatory documentation management
Product information services

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.