Omega-3 fish oil (EPA/DHA) Softgel Capsules

Form: Softgel Capsules

Strength: 500 mg, 1000 mg

Reference Brands: Nordic Naturals, Nature’s Truth, Nature Made(US)

Category: Nutraceuticals

Omega-3 Fish Oil (EPA/DHA) softgel capsules are regulated as dietary supplements in the US and food supplements in the EU. In the US, the FDA oversees safety and labeling, requiring a dossier for claims, mainly focusing on ingredient sourcing, safety, and manufacturing standards. In the EU, compliance with food safety and labeling regulations is mandated. Dossiers should include ingredient safety assessments, manufacturing practices, and efficacy data. For dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional adherence ensures timely approval, safe use, and broad availability of omega-3 supplements, supporting cardiovascular, cognitive, and overall health worldwide.