Comprehensive Biotech Regulatory Solutions
From early-stage analysis through post-market monitoring, we cover the full regulatory lifecycle of your biotech product.
Regulatory Analysis
Product characterization and jurisdictional scoping to determine applicability of Directive 2001/18/EC, Regulation (EC) 1829/2003 (GM Food & Feed), Novel Food Regulation (EU) 2015/2283, or sector-specific frameworks. We identify triggering thresholds, exemptions, and dual-use classification challenges—delivering a compliance roadmap grounded in EFSA opinions and competent authority precedents.
- • Product characterization & GMO/NGT classification
- • Directive 2001/18/EC & Regulation 1829/2003 applicability
- • Regulatory gap analysis & exemption review
Regulatory Strategy
Tailored EU market entry strategy integrating ERA requirements, EFSA guidance documents (e.g., GM plant dossiers, food/feed safety), Member State positioning, and timelines under centralized or national authorization procedures. We align scientific data generation with regulatory expectations to de-risk submissions and accelerate approvals.
- • ERA & EFSA dossier strategy development
- • Regulatory intelligence & Member State analysis
- • Timeline forecasting & risk mitigation planning
Regulatory Studies
Study protocol design, CRO selection, and data package review aligned with EFSA guidance (e.g., 90-day feeding studies, allergenicity, comparative analysis). We ensure GLP compliance, appropriate endpoints, and statistical power to withstand EFSA and Member State scrutiny during the evaluation process.
- • EFSA-compliant study protocol development
- • GLP study design & CRO coordination
- • Data package review & gap closure
Regulatory Policy & Monitoring
Continuous horizon scanning of EU Commission proposals, EFSA guideline updates, and national implementation measures. We contribute to policy consultations, pilot projects, and research initiatives that shape the regulatory landscape—ensuring your organization anticipates changes before they impact market access.
- • EU policy & EFSA guideline monitoring
- • Impact assessment for proposed regulations
- • Contribution to consultations & pilot projects
New Genomic Techniques (NGTs)
Gene editing has opened the door to an exciting new generation of biotechnological innovations. With the UK introducing a dedicated framework for the precision breeding of gene‑edited plants and animals, and the EU now advancing its own tailored rules for New Genomic Techniques (NGTs) in plants, the regulatory landscape is evolving rapidly. These developments promise meaningful simplifications for developers—yet they also add new layers of nuance that must be carefully navigated.
- • CRISPR/gene editing regulatory classification
- • NGT-1 vs. NGT-2 pathway determination
- • Emerging EU NGT regulation compliance
GMO Development Trials
Full-service support for Directive 2001/18/EC Part B (deliberate release) and Part C (placing on the market) submissions—including field trial ERA, containment measures, monitoring plans, and competent authority liaison. We manage clinical, veterinary, and agricultural trial authorizations across EU Member States.
- • Part B field trial ERA & notification dossiers
- • Clinical & veterinary trial authorizations
- • Competent authority coordination & liaison
Market Authorization
End-to-end EFSA dossier preparation and E-Submission Food Chain Platform filing for GM Food & Feed (Regulation 1829/2003), novel foods (Regulation 2015/2283), GM medicinal products, and biologicals. We manage the entire authorization lifecycle—from pre-submission meetings through EFSA Panel evaluation, Member State comments, and Commission decision.
- • EFSA dossier compilation & E-Submission filing
- • GM Food & Feed, novel foods, biologicals approvals
- • EFSA Panel liaison & Commission coordination
Post-Market Compliance
Post-Market Environmental Monitoring (PMEM) plan design, implementation, and reporting under Directive 2001/18/EC and authorization conditions. We manage annual PMEM reports, renewal dossiers, and adaptation to new scientific evidence or regulatory requirements—ensuring continuous compliance and uninterrupted market access.
- • PMEM plan design & implementation
- • Annual monitoring reports to competent authorities
- • Authorization renewal & adaptation to new data
Stewardship Programs
Design and operationalization of Excellence Through Stewardship (ETS) programs—meeting ETS Certified Auditor standards—and coexistence measures like PBI (Preventing Biotechnology Introduction in Conventional Crops). We integrate stewardship protocols with regulatory obligations to demonstrate responsible product lifecycle management and stakeholder engagement.
- • ETS program design & ETS Certified Auditor compliance
- • PBI coexistence protocols & best practices
- • Stakeholder engagement & sustainability demonstration