Morika Bio Technical & Quality Team
Regulatory & Compliance
Navigating global regulatory frameworks across the US, EU, and Asia-Pacific.
Regulatory Landscape
Multi-Region Market Access
Morika Bio technical and quality teams support documentation across major regulatory jurisdictions. Every product is supported with region-specific documentation to support target-market review.
United States
US
HMOs (2'-FL, LNT, LNTr II)
FDA GRAS No-Objection
LNTr II
Regulatory status confirmed by intended use
Salidroside
DSHEA-compliant NDI
Manufacturing
cGMP 21 CFR Part 111
All HMO variants carry FDA GRAS no-objection letters. Yeast-based precision fermentation 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
Manufacturing
FSSC 22000 Certified
FSSC 22000 and Novel Food documentation is supplied according to the applicable product, facility, and target market.
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
Available for applicable product lines
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
Certification copies and scope details are reviewed before release 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.
FDA GRAS
GRAS notification or self-affirmed safety dossiers for applicable US food-ingredient categories.
Halal Support
Certification copies and scope details for applicable product lines.
GMP Compliant
Current Good Manufacturing Practice for dietary supplements.
EU Novel Food
Regulation 2015/2283 authorization for HMO variants.
CITES Compliant
Precision fermentation eliminates need for wild plant harvesting.
Heavy-Metal Tested
ICP-MS verified: Pb, As, Cd, Hg below detection limits.
Regulatory Advantage
Precision Fermentation 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. 3rd-Gen Precision Yeast Synthesis is inherently designed to reduce the endotoxin-management burden associated with bacterial hosts.
Endotoxin Testing
Additional Purification
Regulatory Timeline
Partner Support
Regulatory Documentation on Demand
Morika Bio technical and quality teams provide applicable 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