Business solution


KLIFO Regulatory Affairs Solutions merge competence and experience to assist you in navigating all regulatory requirements. With our extensive experience in interacting with national and regional agencies, we can support all your regulatory affairs needs, throughout your development process – from defining a regulatory development strategy and offering scientific advice to supporting specific submissions.

Anne Tingsgård

VP

Anne Tingsgård holds a Master of Pharmacy degree and joined KLIFO in September 2014. She has more than 30 years’ regulatory affairs experience from both big pharma and private consulting, including two years as CEO and COO in A-consult.

Direct/mobile: +45 44 222 940

Email: anne.tingsgaard@klifo.com

Expertise &
therapy areas


Expertise:

KLIFO Regulatory Affairs Solutions have an expert end to end understanding of all your regulatory needs:

  • Consultancy services – Recommendation and writing of regulatory strategies and solutions
  • Operational services – Compilation, writing, review and submission
  • Regulatory capacity – Flexible and competent regulatory resources
  • Insourcing and outsourcing
  • Consultancy, operational and writing services
  • Providing scientific advice support – Europe & US (e.g. protocol assistance, Pre-IND, type C, End-of-Phase 2 meetings)
  • Preparing clinical trial applications and amendments (advice, compilation, writing, review, submission and follow-up)
  • Preparing your IMPD, orphan drug designation and PIP (advice, writing, compilation, submission, handling during authorities’ assessment)
  • Our services include compilation, review, submission, project management, CP, DCP, MRP, NP, HQ RA & Affiliate RA tasks

Our expert staff


Lene Thrane

Senior Regulatory Affairs Specialist

Lene holds a Master of Pharmacy degree and joined KLIFO in July 2017. She has more than 30 years of regulatory affairs and quality assurance experience within several areas in big pharma. For the majority of these years, Lene has acted as global regulatory lead for various drug development projects in early and late clinical phase development.

Tinni Heiden

Regulatory Affairs Officer

Tinni holds a Master of Pharmacy degree. She joined KLIFO in June 2018 and has 4 years of experience working as a consultant within regulatory affairs. Her focus area has primarily been life cycle management within CMC and labelling changes.

Birgitte Schou

RA Associate

Birgitte joined KLIFO in April 2017. She has more than 14 years’ regulatory affairs experience from pharmaceutical companies. Birgitte’s key competencies are submission to authorities and readiness of documentation and aspects related to these areas.

Dorrit Espersen Juul

Senior RA Specialist

Dorrit joined KLIFO in April 2017. She holds a PhD in Pharmacy and has more than 30 years of global leadership experience in the pharmaceutical industries within drug development, regulatory strategy and regulatory approvals across all major markets. Previously, Dorrit worked within the global regulatory affairs organisation at Novo Nordisk.

Heidi Arp-Nielsen

Regulatory Affairs Specialist

Heidi holds a Master of Pharmacy degree and joined KLIFO in June 2015. She has more than 10 years of experience working with global regulatory affairs in the pharma industry. She has successfully developed and executed regulatory strategies for both development projects and mature products and has contributed to the approval of several MAAs and BLAs.

Joanna Nowak Pedersen

RA Specialist

Joanna holds a Master of Science degree in Food Science and Technology and joined KLIFO in June 2015. She has worked with R&D in global companies since 1998, mainly in regulatory headquarters of both originator and generic pharma. Joanna has solid regulatory experience within product life cycle management, production transfer and applications for new authorisations worldwide.

Lars Olsen

Senior RA Specialist

Lars holds a Master of Pharmacy degree as well as a Bachelor’s degree in Regulatory Affairs. He joined KLIFO in November 2017 with more than 30 years of experience in international regulatory affairs spanning employment at the Danish Medicines Agency, big pharma and private consulting, including three years running his own consultancy business.

Vibeke Kronborg Nielsen

Senior RA Specialist

Vibeke holds a Master of Pharmacy degree and joined KLIFO in October 2014. She has more than 30 years of experience in international regulatory affairs from big pharma within various therapeutic areas. She has worked primarily with development projects spanning from first-in-man trials to approval of a marketing authorisation applications.

Birgitte Kristensen

Senior RA Specialist

Birgitte holds a Master of Pharmacy degree and a Master of Public Administration degree. She joined KLIFO in June 2015 and has more than 30 years of experience in regulatory affairs both from industry and regulatory authorities. For 12 years, Birgitte was VP in Global Regulatory Affairs at ALK-Abelló. Prior to this, Birgitte was head of the Secretariat for Marketing Authorisations at the Danish Medicines Agency and held this position for 10 years.

Mette Møller

RA Specialist

Mette holds a Master of Pharmacy degree. She joined KLIFO in September 2016. Mette has more than 16 years of experience within regulatory affairs from pharma and a few years of experience from medical device. She has broad knowledge of the regulatory tasks and documentation for development and lifecycle management, and also frequently works on optimisation of regulatory processes.

Gitte Tange

Director

Gitte holds a Master of Pharmacy degree and a Diploma in Pharmaceutical Regulatory Affairs. She joined KLIFO in May 2014 and has more than 15 years of regulatory affairs experience. She has experience with both life cycle RA (e.g. MAA procedures, renewals, and variations) and drug development RA (e.g. scientific advice, orphan drug designations, IND/CTA, IB, IMPD, and compassionate use).

Lotte Balle

RA Associate

Lotte holds a Master in Pharmaceutical Chemistry degree. She joined KLIFO in October 2017 and has more than 8 years of experience within regulatory affairs. Lotte’s key competencies are submission to authorities and readiness of documentation and aspects related to these areas.

Dorte Tingskov

Senior RA Specialist

Dorte holds a Master of Pharmacy degree. She joined KLIFO in September 2018 with 19 years of regulatory affairs experience from pharma companies, including four years as department manager. Dorte’s expertise is broad; ranging from generics to biotech products, from early development to life cycle management, and from CMC to clinical trials and labelling.