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

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.
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.
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.
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.
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.
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.

REGULATORY
AFFAIRS
SOLUTIONS

DRUG
DEVELOPMENT
COUNSELLING

CMC
DEVELOPMENT
SOLUTIONS