CMC DEVELOPMENT SOLUTIONS

CLINICAL
TRIAL SUPPLY
SOLUTIONS

Business solution

KLIFO CMC Development Solutions applies scientific excellence to ensure optimal development of your drug candidate. Our experts ensure that your drug presentation is suitable for the relevant pre-clinical and clinical stages. This ensures that information related to your product inspires confidence at the relevant regulatory agencies so that your drug can readily progress to the next stages of development.

Hanne Wulff Nielsen

Director

Hanne holds a Ph.D. in biopharmaceutics and has more than 25 years of pharma industry experience within pharmaceutical product development, business development, project and vendor management, marketing and medical affairs. She joined KLIFO in January 2019 and prior to this she has held specialist and leadership positions in large pharmaceutical companies and in biotech.

Direct/mobile: + 45 44 222 903
Email: moc.ofilk@neslein.ennah

Expertise &
therapy areas

Expertise:

At KLIFO CMC Development Solutions, we offer expert CMC consulting throughout all R&D stages including:

CMC project management
Expert support in formulation and analytical development
Development of quality target product profiles (qTPP) and identification of critical quality attributes (CQA’s)
Implementation of Quality by Design (QbD) in drug development
Performing and facilitating root-cause investigations
Upscaling of manufacturing processes and transfer to CMO, including management of CMOs
Preparation of reports and documentation to support regulatory filings
Planning and conducting of CMC due diligence (DD), including reporting and recommendation

Our expert staff

Steen Gyldendal-Melberg

Senior CMC and QA Advisor

Steen holds a Ph.D. in chemical engineering and is now a senior CMC and QA advisor with 30+ years of experience from the biotech and pharma industry. His competences cover biologics and small molecules drug development, manufacturing and life cycle management and related quality and regulatory aspects. Steen also has significant experience as QP and GMP and GDP Lead Auditor.
Jens Bukrinski

Senior CMC Advisor

Jens holds a Ph.D. in bio-inorganic chemistry and structural biology. He has significant research experience from academia and 10+ years of biologics drug development experience in biotech and pharma, where he has lead several projects and held many functions.
Faramarz Moshfegh

CMC Advisor

Faramarz holds a Master of Science in pharmacy. He has worked with CMC development projects for 10 years in biotech and pharma and most lately as a consultant. Core expertise includes late stage protein formulation development and manufacturing processes.
Lars Foldager

Senior CMC Advisor

Lars holds a Ph.D. in biotechnology and he has worked for 30+ years with bioprocess development and manufacturing in the biotech and pharma industry, 25+ years of which he has been in project management roles. Lars has significant experience in all aspects of CMC development of biologics including strategy, regulatory documentation and management of CROs and CMOs.
Anders Vagnø Pedersen

Senior CMC Advisor

Anders holds an MSc in chemical engineering and a diploma in communication. He brings in 20 years of CMC experience from the biotech and pharma industry covering early to late stage drug development of small molecules and biologics. Anders has managed CRO/CMO projects and held several senior positions.
Jørgen Lang Pedersen

Senior CMC and QA Advisor

Jørgen is a senior CMC and QA consultant with +20 years of QA, QC, GMP and audit experience from the pharma and medical device industry. He has worked as QP for biotech products, GMP Lead Auditor and GDP Responsible Person and has significant experience with stability studies, analytical methods, process validation, batch release, deviations etc. for raw materials, investigational and marketed products and primary packaging material.

CMC
DEVELOPMENT
SOLUTIONS

DRUG
DEVELOPMENT
COUNSELLING