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

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.
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.
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).
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.
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.
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.

REGULATORY
AFFAIRS SOLUTIONS

EXTENSIVE EXPERIENCE OF REGULATORY AFFAIRS

CUSTOMISED SOLUTIONS

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