REGULATORY AFFAIRS SOLUTIONS

CLINICAL
TRIAL SUPPLY
SOLUTIONS

Business solution

KLIFO Regulatory Affairs Solutions can assist you in navigating regulatory requirements related to drug development.

With our extensive experience of interacting with national and regional agencies, we can support all regulatory affairs-related needs throughout the 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:

Regulatory strategy – incl. GAP analysis, regulatory strategy and plan
Regulatory project management and lead
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) incl. submission via EMA’s Clinical Trials Information System
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
Medical devices:
- Regulatory support for medical device development (EU/MDR and FDA), including Notified Body interaction and pre-submission meetings

Our expert staff

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).
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.
Anders Reinholdt Thunell

Document Management Specialist

Anders holds a Mag. Art. degree in History. He joined KLIFO in January 2019 with more than 12 years of experience working with regulatory documentation management within the pharmaceutical industry. Anders expertise include preparation of documents for various regulatory submissions and applying the use of EDMS to support and optimise document management 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.
Lotte Balle

RA Device Specialist

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

Senior 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.

EXTENSIVE EXPERIENCE OF REGULATORY AFFAIRS

CUSTOMISED SOLUTIONS

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DEVELOPMENT
COUNSELLING

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