PharmaLex Group strengthens regulatory expertise in Nordic region

PharmaLex Group, provider of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance, Epidemiology and Risk Management worldwide, has enhanced its senior Regulatory Affairs and Development Consulting team with the addition of Dr Cecilia Falkenberg, a leading expert in pre-clinical/clinical research together with global and local regulatory landscapes.

Dr Cecilia Falkenberg joins PharmaLex as Senior Director, Regulatory Affairs and Development Consulting in the Nordics. With her extensive experience, she will lead local and global projects and support clients with Regulatory Affairs and Medical Writing service demands. Falkenberg is responsible for strategically important new projects, communication with regulatory agencies and management of the local PharmaLex team in the Nordic region.

For the past decade, Falkenberg headed the Regulatory Affairs, Pharmacovigilance and Medical Writing Departments at a clinical CRO, where she was maintaining contacts with clients and regulatory agencies and managing the expanding team of clinical professionals.

Her experience includes strategic project planning and governance in national as well as large international projects, implementing various strategies in accordance to the client’s needs and providing specific guidance.

“I have had a great start at PharmaLex and have seen the broad range of services we are able to offer from pre- and post-authorization,” explained Dr Cecilia Falkenberg.

“We have a strong team who are supported by our many affiliates across the globe”, she added. "We are delighted to welcome Cecilia to the team in the Nordics,” said Torben Nørgaard, Managing Director, PharmaLex Nordics.

“Her extensive experience, coupled with our existing expertise is enabling us to provide clients with added value to both local and global projects,” he added.

Falkenberg has a PhD in Medical Biochemistry from Lund University in Sweden and brings along a considerable knowledge from pre-clinical/clinical research together with a firm grasp of the global and local regulatory landscapes.

You may also like

Regulatory

The right validation model: practical considerations and applications

It is widely accepted that validation in the life sciences industry follows a lifecycle model (1,2). What is not always clear is the specific model — or models — to follow and how to navigate through them in the real world. Hurdles to overcome include the specific deliverables that make up that model and how they change during the various interactions along the validation journey
Regulatory

European Commission adopts proposal to delay MDR deadlines

With thousands of outstanding conformity assessments for medical device certification under the Medical Device Regulation and limited capacity to manage these within the transition period, concerns about widespread product shortages in the EU market have been growing
Regulatory

Investment, outsourcing and globalisation: key trends for 2023

The start of 2023 has been challenging for the pharmaceutical industry. Economic constraints in Europe and the United States, staffing shortages, an increasingly complex regulatory environment and heightened competition for funding is putting pressure on companies
Regulatory

PharmaLex extends reach in Asia with Ascent merger

Headquartered in Tokyo, Ascent employs staff across Asia, and provides country-specific knowledge mixed with strategic advice from a global perspective
Regulatory

PharmaLex taps DocShifter for PDF generation

DocShifter is a document conversion and validation solution for pharmaceutical, biotech and medical device companies
Regulatory

Why Bayesian statistics is revolutionising pharmaceutical decision making

PharmaLex's Bruno Boulanger, Global Head of Statistics and Data Science, and Brad Carlin, Senior Adviser for Statistics and Data Science, explore the growing significance of Bayesian statistics in supporting decision-making across the development and regulatory processes and its potential to improve outcomes for the biopharmaceutical industry
Regulatory

EFSA declares titanium dioxide unsafe for food products

Thomas Eberwein, Head of Pharmaceutical Quality at Pharmalex, explains the EFSA’s recent decision to declare titanium dioxide unsafe for food products, and the implications for manufacturers
Subscribe now