Coldspring Science was founded in 2004 with a mission to provide specialized services and regulatory consulting to globe clients in pharmaceutical, nutraceutical, dietary supplement and food industry.
Coldspring Science was founded in 2004 with a mission to provide specialized services and regulatory consulting to globe clients in pharmaceutical, nutraceutical, dietary supplement and food industry.
Our goal is to ensure your health or wellness product is fully in compliance with regulations and you have confidence in your product's safety, intended effect claims and quality to register successfully in an increasingly competitive marketplace.
The regulatory requirements for health products are constantly evolving. Successful registration filing for pharmaceuticals, food and dietary supplements requires a combination of science-based knowledge and understanding of latest regulations.
Coldspring Science combines expertise from a multi-discipline team of consultants in preclinical research, pharmaceutical science, food science, nutrition and GMP/FSMA to guide our clients to achieve regulatory compliance and gain market entry into USA, Europe, and Australia. Our expert consultants have previously worked either in multinational companies or regulatory agencies.
Helping our clients selecting the best regulatory filing route (such as IND, NDA, ANDA, GRAS, NDIN) , then working with the clients to prepare dossiers and provide step-by-step guidance that leads to successful filing.
Supporting our client’s regulatory filing with appropriately designed study protocols, assisting and supervising preclinical and toxicology studies and guidance for study reporting.
Advising our clients with the most appropriate clinical trial designs and claims, selecting labs，managing clinical trials and consultation on results.
We have experience and networks with high quality peer-reviewed journals to help our clients get their toxicology studies and clinical studies published.
We have expert resources to form independent GRAS panels to verify through scientific procedures that your product meets the “Generally Regarded As Safe" definition.
We partner with many GLP labs in Europe, China, USA providing human cells, and animal cells for the prediction of toxic and long-term effects of agents on the human body and the environment. Our cell culture systems are important for your day-to-day work. Human and non-human hepatocytes are available as fresh or cryopreserved.
Product Category:
Cell and Tissue Products
Liver products
Human liver cells
Animal liver cells
Liver subcellular fractions
Skin products
Skin tissues
Skin discs & dermatomed skin
Fibroblasts
Keratinocytes
Other organs and body fluids
Trout S9 fraction: intestine, gill, brain
Consumables
Cell Culture Media
3D Hepatocyte Maintenance Medium
Long Term Hepatocyte Culture Medium
Short Term Hepatocyte Culture Medium
Thawing and Plating Kits
Collagen products
ULA plates
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