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Qualified Person Services and pharma Regulatory Support

Your partner of choice when it comes to navigating the complex pharmaceutical regulatory landscape

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Qualified Persons in pharma (QPs) and pharma regulatory support are vital in CDMOs, holding responsibility for compliance with pharmaceutical legislation, product quality, market access, drug quality risk management, the process of product release, and expert advice.

In the European Union, it is a mandatory role within the pharmaceutical industry.
  • Premium QP services and comprehensive global regulatory affairs services
  • The QP certifies that each batch of a medical and pharmaceutical product is manufactured and controlled in accordance with the law and regulations, Good Manufacturing Practice (GMP), and the marketing authorization (or IND/IMPD) of the product
  • Guidance for navigating the regulatory landscape of the pharmaceutical industry, advising on how best to conform with the various regulations
  • We promote rapid access to the market, through swift and effective batch-releasing in accordance with our strict compliance standards
  • We excel at navigating through complex regulatory areas, and finding the best solutions as you go through the approval process
  • Expertise in the preparation of CMC (Chemistry, Manufacturing, and Controls) and professional approach to thorough, accurate documentation
  • Enhance your operational efficiency.

Batch Confirmation and Certification

With CARBOGEN AMCIS, you can be sure that each pharmaceutical drug product produced is safe and compliant. Our renowned qualified person (QP) services focus on robust batch confirmation / certification– ensuring that every batch meets the highest quality and regulatory standards.

With a steadfast priority on compliance and accuracy, we take the time to carefully review and verify every product batch during processing to ensure compliance with a strict set of international regulatory requirements before its final release.

Trust us to be your partner in excellence, streamlining your products’ journey from production to market.

Batch Confirmation and Certification
CMC Section Support

CMC Section Support

Chemistry, Manufacturing, and Controls (CMC) support is a critical component in the drug development dynamic for the pharmaceutical industry and CDMOs.

As such, CMC provides a broad and critical integration of the drug development process, ensuring the ongoing consistency of compliance, safety, efficacy, and the well-being of the consumer as a whole. Thus, a drug product is unlikely to be approved by the regulatory body without a good and thorough CMC section.

As such, CMC provides a broad and critical integration of the drug development process, ensuring the ongoing consistency of compliance, safety, efficacy, and the well-being of the consumer as a whole. Thus, a drug product is unlikely to be approved by the regulatory body without a good and thorough CMC section.

  • Our team specializes in creating strategies to address the specific requirements of each transfer and guaranteeing a seamless transition and commercialization process
  • In the preparation of detailed CMC sections for IND (Investigational New Drug) and IMPD (Investigational Medicinal Product Dossier) submissions.
  • And also have a broad experience in the preparation of AMM/NDA (Authorization for Marketed Medicinal Products/New Drug Application) submissions.
  • If you already have your own regulatory resources, CARBOGEN AMCIS can provide a complete CMC review.

Indeed, the close collaboration with development, manufacturing and analytical experts on site results in registration documents with appropriate level of detail, reducing the number of post-approval changes, fewer Health Authority questions and thus faster approvals.

Our regulatory support includes validation activities that assure the robustness and compliance of your products. CARBOGEN AMCIS provides strategic and thorough CMC section support that ensures pharmaceutical quality and rapid progress in the development of drug products.

For more information download our Development & Aseptic Production of Drug Products brochure.

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