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Eddingpharm to develop and commercialise Ablynx's ozoralizumab in China By PBR Staff Writer
Belgian biopharmaceutical firm Ablynx has signed an exclusive license agreement with Eddingpharm to develop and commercialize its anti-TNFa Nanobody, ozoralizumab (ATN-103) in China for all indications, including rheumatoid arthritis (RA).
Contract Research & Services > Contract Services > News
Innovus and DanaLife ink marketing, distribution deal for Zestra in alternative markets By PBR Staff Writer
Innovus Pharmaceuticals has signed an exclusive marketing and distribution agreement to grant Denmark-based DanaLife an 18-month worldwide distribution right (excluding Canada), to market and sell its topical consumer care product Zestra.
Contract Research & Services > Contract Services > News Concert Pharma secures $2m payment for new drug product AVP-786 By PBR Staff Writer
Concert Pharmaceuticals has received a $2m milestone as part of a development and license agreement with Avanir Pharmaceuticals for the clinical progression of AVP-786 in patients with major depressive disorder (MDD).
Contract Research & Services > Contract Services > News
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Regulatory / Clinical Support
NSF Pharma Biotech offers expert FDA regulatory/clinical support and consulting services to all sizes of pharmaceutical and biotech companies, investment firms, and regulatory or litigation counsel who need experts to interpret or navigate the intricacies of FDA pharmaceutical and biotechnology regulations.
Contract Research & Services > Contract Services > Products
Regulatory Enforcement Action Support
Regulatory inspections from authorities around the world may require pharma biotech companies to respond to specific enforcement actions. Helping you with regulatory compliance is the core of our expertise. Our team includes former U.S. FDA and UK MHRA inspectors and experts with decades of experience helping companies develop strategic plans to address enforcement actions (FDA, MHRA, Health Canada, etc.)
Contract Research & Services > Contract Services > Products
Pharma Quality Systems and Compliance
Strong and robust quality systems are required for companies to consistently and reliably produce safe, high-quality products and services. Not addressing concerns highlighted in FDA 483s and FDA warning letters can potentially halt production or, worse, result in a recall, import bans, detention or product seizure, which can damage your organisation’s pipeline, financial well-being and reputation. With relentless, often subtle, changes to guidelines released by regulatory authorities around the world, it can be challenging to stay up to date.
With substantial experience in creating, implementing, reviewing and remediating quality systems for a variety of organisations, we at NSF Health Sciences Pharma Biotech are the premier source for assistance with any question or issue related to quality systems.

Contract Research & Services > Contract Services > Products
Does Your Pharmaceutical Quality System Improve Your Competitive Edge?
There are some companies who believe that their Pharmaceutical Quality System (PQS) exists purely for regulatory compliance. We think this attitude is outdated and plainly wrong. At NSF-DBA, we believe that your PQS has only one purpose: to improve your competitive edge by guaranteeing the manufacture of high quality medicines at the lowest possible cost.
Contract Research & Services > Contract Services > Case Studies
Eddingpharm to develop and commercialise Ablynx's ozoralizumab in China
By PBR Staff Writer
Belgian biopharmaceutical firm Ablynx has signed an exclusive license agreement with Eddingpharm to develop and commercialize its anti-TNFa Nanobody, ozoralizumab (ATN-103) in China for all indications, including rheumatoid arthritis (RA).
Contract Research & Services > Contract Services > News
Innovus and DanaLife ink marketing, distribution deal for Zestra in alternative markets
By PBR Staff Writer
Innovus Pharmaceuticals has signed an exclusive marketing and distribution agreement to grant Denmark-based DanaLife an 18-month worldwide distribution right (excluding Canada), to market and sell its topical consumer care product Zestra.
Contract Research & Services > Contract Services > News
Fujifilm Diosynth Biotechnologies Expands Cell Culture Manufacturing Capacity
Fujifilm Diosynth Biotechnologies has announced continued expansion of its cell culture manufacturing capabilities with the addition of two 2,000L single-use bioreactors. One each of these is being installed at the company's sites in Research Triangle Park (RTP), NC, USA and Billingham, UK.
Contract Research & Services > Contract Services > Press Releases
Concert Pharma secures $2m payment for new drug product AVP-786
By PBR Staff Writer
Concert Pharmaceuticals has received a $2m milestone as part of a development and license agreement with Avanir Pharmaceuticals for the clinical progression of AVP-786 in patients with major depressive disorder (MDD).
Contract Research & Services > Contract Services > News
Recipharm, Isofol Medical collaborate to manufacture Modufolin
Recipharm and Isofol Medical, a Gothenburg-based pharmaceutical company developing novel products for unmet needs within oncology, are pleased to announce the formation of a collaboration to strengthen the development program of Isofol’s lead drug candidate Modufolin.
Contract Research & Services > Contract Services > News
AB SCIEX, Dalton Pharma partner to advance antibody-drug conjugate analysis
AB SCIEX and Dalton Pharma Services (Dalton) have announced a research collaboration to develop Antibody-Drug Conjugate (ADC) analysis capabilities.
Contract Research & Services > Contract Services > News
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