REGULATORY AFFAIRS SOLUTIONS

CLINICAL
TRIAL SUPPLY
SOLUTIONS

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: moc.ofilk@draagsgnit.enna

Expertise &
therapy areas

Expertise

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

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, IND, 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, IND, HQ RA & Affiliate RA tasks

Our expert staff

Lene Thrane

Senior RA 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.
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.
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.
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.
Heidi Arp-Nielsen

RA 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.
Tinni Heiden

RA 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.

REGULATORY
AFFAIRS SOLUTIONS

EXTENSIVE EXPERIENCE OF REGULATORY AFFAIRS

CUSTOMISED SOLUTIONS

DRUG
DEVELOPMENT
COUNSELLING

CMC
DEVELOPMENT
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