At FyoniBio we offer biopharmaceutical services at different stages of drug development.
We support biotech and pharma companies in their preclinical and clinical development of small oligonucleotides to large antibodies by PK, PD, ADA and biomarker assay development, validation and bioanalytical sample analysis according to GCLP and current ICH, FDA, and EMA guidelines. An important capability of FyoniBio is the fast-single nucleotide polymorphism analyses of clinical trial patient samples using the Lightcycler® and DNA melting curve analysis.
In addition, we offer cell line contract development for the production of biologics. FyoniBio’s portfolio comprises the human GlycoExpress® platform as well as the CHO platform technologies CHOnamite® and CHOFlow®. Our CHO platforms combined with biologic tailored upstream and downstream processes yield mean titres of 10 g/L (mAb). We provide state-of-the-art CMC analyses including mass spectrometry with a focus on glycan post translational modifications (PTM).
Since 2007, Meisys has been providing medical and scientific knowledge solutions for companies in the healthcare sector. We specialize in supporting the entire product life cycle, acting as a strategic partner in medical, regulatory, quality, and pharmacovigilance areas.
We have a multidisciplinary team with extensive experience in human and veterinary medicines, medical devices, cosmetics, and food supplements.
Committed to quality, we are ISO 9001 certifiedand apply internal quality processes that ensure the efficiency, rigor, and professionalism of all our services.
Research Mentor(RM) specialize in helping global nutraceutical and food companies successfully enter the Korean market. Founded on 2016, Research Mentor has supported 100+ clinical trials, high success rate in MFDS approval and built a trusted network of partners worldwide, including the U.S., Canata, Japan, and Europe.
RM’s services include:
– Human clinical trials for health functional foods: supports and manages the full clinical trial process to evaluate the efficacy and safety of health functional foods.
– Statistical Analysis: comprehensive data processing, including clinical data analysis, post-hoc testing, advanced supplementary analysis, and etc,.
– MFDS Temporary Approval & Individual Recognition support: supports the goverment agency’s approval process for unlisted ingredient, including the dossier preparation, gap analysis, gap filling, and regulatory affair.
-Regulatory feasibiilty assessments for ingredients and products:
review whether ingredients or products can be marketed in Korea as foods or health functional foods under applicable Korean regulations.
– Strategic market entry consulting for global brands:
provides guidance on the most appropriate pathways and processes for entering the Korean market, considering Korea’s regulatory environment and market trends.
