LINK Medical AS og Melanor inngår samarbeidsavtale
LINK Medial AS og Melanor har inngått samarbeidsavtale som gir medlemmer tilgang til nødvendig kompetanse og rådgiving på gunstige vilkår i prosessen mot registering av medisinsk utstyr.
Categories: regulatory affairs
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Pharm Assist is now part of LINK Medical, making the Regulatory team one of the largest and unique in Northern Europe
Pharm Assist is now part of LINK Medical, making the Regulatory team one of the largest and unique in Northern Europe
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Strategic Advice Provides a Shortcut to Success
Many biotech companies have a strong research base but lack the knowledge and experience needed to bring their products closer to the market. LINK Medical Research can help to map the strategic pathway.
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Another milestone reached for AlzeCure's Phase II clinical trial in neuropathic pain with non-opioid ACD440
The first patient has been enrolled in the phase II clinical trial for neuropathic pain treated with the non-opioid ACD440. The Phase II clinical trial is a double-blind, placebo-controlled, randomized cross-over study evaluating the efficacy, safety, and pharmacokinetics of AlzeCure's leading drug candidate in pain, ACD440. Results from the study are expected in mid-2023.
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Key considerations to be aware of with Clinical Trial Regulation (CTR) EU No 536/2014
The Clinical Trial Regulation (Regulation (EU) No 536/2014) will replace the Clinical Trials Directive 2001/20/EC and aims to ensure a higher level of harmonization of the rules for authorizing and conducting clinical trials throughout the EU thus making it more attractive to conduct clinical trials in the EU. The new regulation goes into effect on the 31st of January 2022.
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LINK Medical expands its regulatory services team, strengthening its IMPD & CMC capabilities
LINK Medical, the Northern European clinical research organization (CRO), recently announced the expansion of its regulatory team with the recent appointment of new regulatory directors in Norway, Sweden and Denmark.
