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:

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

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.
Dorrit Espersen

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.
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.
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.
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.
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.

REGULATORY
AFFAIRS
SOLUTIONS

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DEVELOPMENT
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DEVELOPMENT
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