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

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.
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.
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.
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).
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.
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.

REGULATORY
AFFAIRS
SOLUTIONS

DRUG
DEVELOPMENT
COUNSELLING

CMC
DEVELOPMENT
SOLUTIONS