Morika Bio Global Quality Unit
Regulatory & Compliance
Navigating global regulatory frameworks across the US, EU, and Asia-Pacific. Manufactured for Morika Bio.
Regulatory Landscape
Multi-Region Market Access
Morika Bio Global Quality Unit ensures compliance across all major regulatory jurisdictions. Every product is supported with region-specific documentation for seamless market entry.
United States
US
HMOs (2'-FL, LNT, LNTr II)
FDA GRAS No-Objection
LNTr II
First FDA GRAS globally
Salidroside
DSHEA-compliant NDI
Marine Peptides
FDA GRAS self-affirmed
Manufacturing
cGMP 21 CFR Part 111
All HMO variants carry FDA GRAS no-objection letters. BioSync™ yeast synthesis eliminates endotoxin concerns flagged in E. coli-derived alternatives.
European Union
EU
HMOs (2'-FL, LNT)
EU Novel Food Reg. 2015/2283
LNTr II
Dossier under review
Salidroside
Existing food supplement
Marine Peptides
Traditional use, authorized
Manufacturing
FSSC 22000 Certified
Our FSSC 22000 certification streamlines EU market access. Novel Food applications are supported by comprehensive toxicological dossiers from our Morika Bio Global Quality Unit.
Asia-Pacific
APAC
China (SAMR)
New food ingredient filing
Japan (MHLW)
Foods with Function Claims
South Korea (MFDS)
Health functional food
ASEAN
Harmonized food supplement
Halal Certification
Global Halal certified
Our Shanghai APAC headquarters provides on-ground regulatory support for China SAMR filings and regional market access across key Asian markets.
Certifications
Comprehensive Quality Assurance
Every certification is verified through our Morika Bio Global Quality Unit and maintained with continuous audit programs.
FDA GRAS
No-objection letters for all HMO variants. First globally for LNTr II.
FSSC 22000
Food safety management certification for manufacturing facilities.
ISO 9001:2015
Quality management system certification across all operations.
Halal Certified
Global Halal certification for all product lines.
GMP Compliant
Current Good Manufacturing Practice for dietary supplements.
EU Novel Food
Regulation 2015/2283 authorization for HMO variants.
CITES Compliant
BioSync™ fermentation eliminates need for wild plant harvesting.
Heavy-Metal Tested
ICP-MS verified: Pb, As, Cd, Hg below detection limits.
Regulatory Advantage
BioSync™ Eliminates E. coli Regulatory Burden
Legacy E. coli-based fermentation systems require extensive endotoxin testing, additional purification steps, and heightened regulatory scrutiny across all jurisdictions. BioSync™ 3rd-Gen Precision Yeast Synthesis is inherently endotoxin-free, streamlining the regulatory pathway for faster market access.
Endotoxin Testing
Additional Purification
Regulatory Timeline
Partner Support
Regulatory Documentation on Demand
Morika Bio Global Quality Unit provides comprehensive regulatory support packages tailored to your target market.
FDA GRAS No-Objection Letters
EU Novel Food Application Dossiers
Toxicological Safety Assessments
Stability Testing Data (ICH Zones I-IV)
Certificate of Analysis (batch-specific)
Allergen & GMO Status Declarations
Country-Specific Import Documentation
Halal & Kosher Certification Copies