FDFs
APIs
Manufacturing
Engineering
Services
EUROPEAN REGULATORY REPRESENTATIVE SERVICES EU AR REPRESENTATIVE
S.B. Pharma has 14 years of EU-authorized representative experience with the German (BfArM) competent authorities. We can guarantee your company’s compliance with the MDR, IVDR, Contingency MedDO, and your device’s continuous placement in the EU Market.
S.B. PHARMA FOCUS
• Strategic Partnerships 🔗: Lead partnerships in the pharmaceutical sector, ensuring delivery of quality APIs, excipients, FDFs and intermediates at German standards and highly competitive prices.
• Supplier Agility 🔄: Advocate a supplier-agnostic approach to maximize quality and cost-effectiveness, with full transparency in all dealings.
• Technology Integration ⚙: Direct technology and logistics optimizations to enhance supply chain efficiency and transparency.
• Regulatory Compliance 📜: Navigate complex regulatory environments to maintain compliance and ensure product integrity for production and patient.
S.B. PHARMA OFFERS
• Independent Benchmarking and supply of APIs, Excipients, FDFs and intermediates for current and future business.
• Information Management on Market Developments and Product Changes.
• Support with Regulatory & Documentation issues from Launch to Commercial Implementation.
• Stockpiling as part of supply contracts and timely deliveries.
• Organization of Joint Meetings with Manufacturers and Customers at Trade Fairs and Trips.
• Support and Organization of necessary Quality Audits (including EU GMP Audits).
• Evaluation of possible Contract Manufacturers.
S.B. PHARMA: Your Trusted Partner for Tailored Solutions and EU GMP Compliance
Our EU GMP compliance services are structured into five phases:
Phase 1: EU GMP reviews, gap analysis, and remediation
Phase 2: GMP training
Phase 3: EU GMP audit preparation
Phase 4: EU GMP pre-inspection audit conducted by our European-based partner
Phase 5: Final liaison with EU authorities
Our experienced consultants will not only train but also lead your team towards successful EU GMP certification, instilling a GMP culture and mindset that leaves no doubt about your readiness to comply with EU GMP requirements.
With our meticulous approach and rigorous GMP reviews and gap analysis, we ensure alignment of your facility documentation and processes with EU GMP regulations and guidelines well before the arrival of auditors.
Furthermore, our European-based third-party EU GMP pre-inspection auditor conducts a thorough assessment of your facility’s readiness, providing assurance prior to inviting EU regulators for the audit.
Contact S.B. Pharma today for a right-first-time solution to your EU GMP compliance needs, and embark on a journey towards seamless regulatory compliance and market access.
