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services

Core Service Areas

1. Regulatory Strategy & Planning

Comprehensive roadmap development for successful market entry

  • Regulatory Pathway Assessment: Identification of optimal FDA pathways (510(k), De Novo, PMA, NDA, BLA)

  • Integrated Regulatory Strategy: Development of cross-functional plans aligning regulatory, clinical, and quality requirements

  • Pre-Submission Planning: Gap analysis and readiness assessment for FDA interactions

  • Lifecycle Management: Strategic planning for post-market changes and product iterations

  • Global Expansion Strategy: Coordinated regulatory plans for US, EU, and international markets

2. US Agent Services

Your trusted regulatory representative for seamless FDA compliance

  • Official US Agent for Foreign Companies: Complete regulatory representation services

  • FDA Communication Management: Handling of all correspondence, inquiries, and requests

  • Facility Registration & Listing: Management of all FDA establishment registration requirements

  • Importer of Record Services: Support for customs clearance and import compliance

  • Emergency Response Coordination: 24/7 availability for FDA emergencies and recalls

3. Submission Management & Documentation

Flawless preparation and submission of regulatory applications

  • Application Preparation: Complete drafting and compilation of 510(k), De Novo, PMA, IND, NDA, BLA submissions

  • eCTD Publishing Services: Expert electronic Common Technical Document preparation and submission

  • Technical File Compilation: Structured documentation meeting FDA and MDR requirements

  • Quality System Documentation: Preparation of DHF, DMR, and DHF records

  • Rapid Response Support: Management of FDA additional information requests

4. Quality & Compliance Systems

Building sustainable quality systems for long-term success

  • QMS Implementation: 21 CFR Part 820, 211, 111 compliance system development

  • GAP Assessments & Audits: Comprehensive compliance evaluations and remediation plans

  • Supplier Quality Management: Vendor qualification and supply chain compliance

  • CAPA System Development: Effective corrective and preventive action systems

  • Internal Audit Programs: Ongoing compliance monitoring and improvement

5. Clinical & Technical Evaluation

Science-driven evidence generation for regulatory success

  • Clinical Evaluation Strategy: Planning and documentation per regulatory requirements

  • Biocompatibility & Safety Testing: Strategic planning and evaluation of biological safety

  • Software Validation: SaMD, SiMD, and cybersecurity compliance support

  • Human Factors Engineering: Usability engineering and validation study support

  • Performance Testing Strategy: Bench testing and laboratory study planning

6. Post-Market Surveillance & Vigilance

Proactive monitoring and compliance for commercial products

  • PMS System Development: Comprehensive post-market surveillance program setup

  • Adverse Event Reporting: Management of MDR, MedWatch, and vigilance reporting

  • Periodic Safety Reports: Preparation and submission of required periodic updates

  • Field Action & Recall Management: Support for market withdrawals and corrections

  • Trend Analysis & Signal Detection: Proactive risk monitoring and management