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.

Lars-Bjørn Christensen

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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
Medical devices:
- Drug-device combinations
- Container closure selection

Our expert staff

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.
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.
Jes Jacobsen

Senior CMC Expert

Jes holds a Master of Pharmacy degree and joined KLIFO in May 2017. He has more than 30 years of experience within R&D with special focus on topics related to CMC/analytical development.
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.
Milad Khorasani

Senior CMC Expert

Milad holds a Ph.D. in Pharmaceutical Technology and Engineering. He is a Pharmaceutical expert within drug substance (DS), drug product (DP) development and manufacturing and has +10 years of industry experience in scientific, technical and CMC project management roles. Core expertise includes CMC activities/documentation, formulation of various dosage forms both small and large molecules, Quality by Design (QbD), Design of Experiments (DoE), Process Analytical Technology (PAT) and Data Analytics.
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

SCIENTIFIC EXCELLENCE
FOR OPTIMAL DRUG DEVELOPMENT

EXPERT CMC CONSULTING EVERY STEP OF THE WAY

DRUG
DEVELOPMENT
COUNSELLING