Regulatory Affairs Services

Global Expertise for Regulatory Compliance and Market Success

Effector Life Science provides end-to-end regulatory affairs solutions and quality assurance services to support pharmaceutical, biotech, and medtech companies throughout the product lifecycle. Our expert team helps you navigate evolving global regulations, ensure compliance, and accelerate product access to global markets.

Regulatory Strategy & Planning

Global Planning Aligned with Your Product and Business Objectives

• Development of global and regional regulatory strategies

• Regulatory gap analysis and risk-based planning

• Global regulatory landscape assessments and intelligence

• Regulatory due diligence for licensing, partnership, and M&A activities

• Multi-regional and harmonized regulatory strategy development

Regulatory Submissions

Full Lifecycle Submission Support Across Major Global Markets

• IND, NDA, ANDA, BLA, and MAA submissions

• 510(k), PMA, and De Novo applications for medical devices

• Clinical Trial Applications (CTAs) and amendments

• Regulatory publishing and eCTD submissions (FDA, EMA, MHRA, TGA, Health Canada)

• Post-approval submissions and Annual reports

Regulatory Agency Engagement

Effective Communication with Regulatory Authorities

• Regulatory authority meeting strategy and planning

• Briefing document preparation and submission

• Representation and support during agency interactions

• Post-meeting follow-up and regulatory action tracking

Regulatory Intelligence & Information Management

Stay Ahead with Reliable, Real-Time Insights

• Continuous monitoring of evolving regulatory requirements

• Impact analysis and interpretation of regulatory change

• Customized regulatory landscape reports by region and product class

• Regulatory information management support for global compliance

Labeling & Documentation Support

• Regulatory labeling development and compliance verification

• Preparation of package inserts, product monographs, mockups, and annotations

• Comparative labeling assessments across regulated markets

• Technical medical writing and regulatory publishing support

Regulatory Project Management

Hands-On Support to Drive Timely, Compliant Execution

• Day-to-day coordination across stakeholders and sites

• Deliverable tracking and risk mitigation

• Proactive communication to keep programs on schedule

U.S. Regulatory Agent Services

Effector Life Science can serve as your designated U.S. Agent for FDA communications, inspections, and submissions, ensuring your international operations are fully supported for U.S. market entry and compliance.

Effector Life Science is your strategic partner for global regulatory success—from preclinical planning through post-market compliance. Let our seasoned regulatory professionals help you mitigate risk, streamline execution, and achieve your commercialization goals with confidence.

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