Regulatory hurdles can significantly can slow down your project, increase costs, and put your market entry at risk. Our expert team provides guidance and solutions to minimize product development time, accelerate product and agency approvals. Renejix regulatory specialists have prepared hundreds of submissions and are experienced in handling a wide range of therapeutic areas and project types (small molecules, NCEs, established dosage forms).
Customize regulatory affairs services for global markets and and receive support the full product lifecycle of your products. Receive support at every stage, either by reviewing submissions in coordination with your existing regulatory team or by full-service authoring and publishing.
Regulatory Compliance
Comprehensive Regulatory Support
📌 Expert Knowledge of Compliance Standards – Our team stays up to date with compounding pharmacy regulations, including USP <795>, <797>, and <800>, as well as FDA, DEA, and state board requirements.
📌 Strategic Regulatory Guidance – We help pharmacies navigate complex compliance challenges, ensuring they meet all safety, purity, and documentation requirements.
📌 Supplier & Ingredient Compliance – CPNRX carefully vets suppliers to ensure all ingredients and materials meet strict regulatory standards and quality benchmarks.
Quality Assurance & Product Integrity
✅ Strict Adherence to GMP & Industry Protocols – Every sourced ingredient and supply is verified for consistency, potency, and purity.
✅ Continuous Monitoring & Adaptation – We proactively track regulatory changes and adapt sourcing strategies to keep your pharmacy in compliance.
✅ Risk Management & Safety – We identify and mitigate risks early to ensure consistent quality, safety, and regulatory adherence.
Data Integrity & Documentation
🔍 Transparent & Verified Sourcing – All suppliers undergo rigorous quality assessments to ensure compliance with regulatory bodies.
📄 Thorough Recordkeeping – Our members benefit from streamlined documentation to simplify inspections and audits.
🔬 Focus on Patient Safety & Product Efficacy – Every ingredient sourced through CPNRX is backed by quality assurance to maintain product integrity and safety.
Why Choose CPNRX?
🌍 Global Compliance Expertise – We help pharmacies navigate both U.S. and international regulations.
📉 Reduce Compliance-Related Costs – Avoid regulatory pitfalls that lead to costly delays and fines.
🔄 Stay Ahead of Regulatory Changes – Our team continuously monitors industry updates to keep your pharmacy compliant.
🤝 Personalized Support & Training – Our experts provide guidance, education, and resources to help your pharmacy stay compliant with evolving standards.
Partner with CPNRX Today!
Ensuring quality, compliance, and affordability in compounding doesn’t have to be difficult—CPNRX makes it seamless.
📅 Schedule a meeting today to learn how CPNRX can optimize your pharmacy’s procurement and regulatory strategies! Prefer an in-person visit? We’ll come to your pharmacy and discuss solutions tailored to your needs!
