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Local QP Support for Batch

Ensure Quality and Compliance from Manufacturing to Market While Navigating Regulatory Challenges with Our Expert QP Solutions

We assure compliant batch release by our local expertise and global excellence

We offer top-notch local Qualified Person (QP) support for batch release; ensuring pharmaceutical products meet regulatory standards with precision and expertise. Our services are tailored to your market’s specific needs, facilitating seamless and compliant batch release processes.

When a pharmaceutical product is released into a clinical trial or the market in the European Union, it must be certified by a Qualified Person (QP). This process, known as a QP release, occurs after the drug is released. Pharmaceutical products imported into the EU from outside the EU are also subject to QP certification and release. Zenovel offers QP services, and it is recommended to explore their range of activities and benefits.

Responsibilities of the Qualified Person (QP)

The QP is responsible for ensuring that pharmaceutical products meet high standards and quality attributes, regardless of the manufacturing location. According to Article 48 of Directive 2001/83/EC, the QP must certify that each batch of pharmaceutical products complies with the established quality standards. Before a product is released to the market or used in clinical trials, the QP must verify that the product adheres to GMP guidelines and that all necessary documentation is authorized. Additionally, the QP ensures that the distribution of pharmaceutical products complies with both local regulations and international laws in the respective countries.

To guarantee high standards for pharmaceutical goods require strict supervision and quality attributes, regardless of manufacturing location. Article 48 of Directive 2001/83/EC mandates the Qualified Person (QP) to attest to batch compliance with quality standards. Before market release or clinical trial, QP must confirm GMP manufacturing guidelines, high-quality medicinal products, and authorized documentation. Distribution of pharmaceutical products must comply with local laws and local laws in each county.

Activities performed by our local QP support

We offer top-notch local Qualified Person (QP) support for batch release; ensuring pharmaceutical products meet regulatory standards with precision and expertise. Our services are tailored to your market’s specific needs, facilitating seamless and compliant batch release processes.
The company offers a range of services including
  • QP Batch Certification
  • QP Batch Release
  • Audits and reviews of batch records
  • Provision of certificates of release
  • Management of recalls, complaints, suspensions
  • Batch withdrawals
  • Supervision of serialization alerts
  • Contact with competent healthcare authorities
  • Fiscal flow-chain management
  • Physical flow-chain optimization
  • Logistics optimization
  • Quality control assurance
  • Batch expiry extension assistance.
  • Additional services include audits of medicinal product manufacturing sites, Active Products Ingredient (API) manufacturing sites, support for manufacturers in EU GMP certification, scientific support for manufacturers and marketing authorization holders, regulatory affairs consultancy services, and collaboration with reliable subcontractors for analytical and microbial sample testing.
  • Our services
  • Why Choose Zenovel ?
  • Expertise and Experience

Extensive knowledge and experience in pharmaceutical quality and regulatory affairs.

  • Localized Knowledge

In-depth understanding of local regulations and market

  • Quality Commitment

Dedicated to maintain highest quality standards compliance.
Ensure products are safe and effective.

  • Client-oriented Approach

Work closely with clients
Provide personalized support and solutions.

Reach out to us for any inquiries or support needs.
Contact us

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We provide affordable, innovative, and high-quality solutions to pharma industry with ethics driven research and increasing accessibility to high quality medicine worldwide
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  • India
  • Australia
  • 9, Blaxland Avenue,
    Cranbourne North,
    Victoria-3977, Australia
  • Brazil 
  • Rua Praia do Tubarão, Quadra C,Loteamento Eco Vilas, Lote 13 – Vilas do Atlântico 42708-730 Lauro de Freitas, Bahia, Brazil
  • Brazil 
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  • 911 Hwy 6 Hitchcock,
    Texas, 77563, USA
  • Canada
  • 215 Moorlands Crescent,
    Kitchener, Ontario N2P 0C3
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  • Zhenjiang Tech Park, Shanghai China
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