Regulatory consulting services

Regulatory consulting services Companies (20)

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Regulatory consulting services Products (24)

  • Product Batch release

    We take responsibility for releasing your drug batches in accordance with the requirements of the EU GMP guidelines and the German Medicinal Products Act (AMG).

    Our services at a glance: • Batch release in accordance with EU GMP Annex 16 by our QPs • Batch certification for human and veterinary...
    Batch release

  • Product Biologic drug substance CDMO services

    From early development, including mammalian cell line development, cell culture development, and process development, through to pre-clinical production and commercial supply, Patheon by Thermo Fisher Scientific provides CDMO services for protein-based biologic therapeutics. Patheon offers biotech and ...
    Biologic drug substance CDMO services

  • Product SFDA Registration - Saudi Arabia

    Drug registration in Saudi Arabia (Saudi Food and Drug Authority - SFDA).
    SFDA Registration - Saudi Arabia

  • Product CDMO Services

    Blow-Fill-Seal is the most economical way to get your liquids or semi-solids into the perfect shape. But investing in your own equipment doesn't always pay off. For these cases, there is our CDMO service. This means that you have a complete GMP infrastructure, bottelpack technology in various configuration...
    CDMO Services

  • Product Autoinjector development services

    SHL Medical’s commitment to innovation has driven our leadership in the drug delivery industry. We offer vertically integrated development services to ensure the production of our self-injection systems are delivered with unparalleled speed, quality, and reliability. 
    Autoinjector development services

  • Product Regulatory Support

    Our Chemistry, Manufacturing and Controls (CMC) specialists help customers manage the product's compliance at every step, from clinical development to market authorization. With decades of experience, our experts provide support in navigating regulatory milestones, including site registration, product regi...
    Regulatory Support

  • Product GCP Services(Good Clinical Practices)

    We offer various GCP services which can help the clients across globe, ranging from audits to monitoring services. We provide comprehensive GCP Quality Compliance services to the pharmaceutical industry. Our GCP consulting services are characterized by:

    1) Knowledge: Various regulatory requi...
    GCP Services(Good Clinical Practices)

  • Product GMP audits

    Ideolon’s GMP audit services provide end-to-end solutions for supplier qualification, including audit planning, execution, CAPA follow-up, and closure. With experienced auditors and global regulatory expertise, we help ensure compliance with standards like USFDA, EMA, UKMHRA, ICH, and more.
    GMP audits

  • Product Pharmacovigilance / Drug Safety

    We are an experienced and interdisciplinary team. Based on good pharmacovigilance practice (GVP) recommendations we provide comprehensive and individual support for all pharmacovigilance matters.

    Pharmacovigilance services at a glance:
    • Adoption of responsibility as EU-QPPV and graduated pla...
    Pharmacovigilance / Drug Safety

  • Product GMP Services(Good Manufacturing Practices)

    We offer various GMP services which can help the clients across globe, ranging from audits to various consulting services.

    We provide following comprehensive GMP Quality Compliance services to the pharmaceutical industry.

    • Audits 

    • API Audit Reports 

    • QMS/Complia...
    GMP Services(Good Manufacturing Practices)

  • Product Usability IEC 62366-1 as a service

    Within 2 to 4 weeks, we can design and deliver batches ranging from 5 to 100 units, replicating the final commercial configuration of a medical device :
    • High-fidelity device prototypes
    • Precision labeling and marking
    • Professionally formatted documentation (IFU, quick guid...
    Usability IEC 62366-1 as a service

  • Product Regulatory Affairs

    At YallaRx, we specialize in regulatory support for different product categories:

    • Rx and OTC medicines • Dietary supplements • Cosmetics and perfumes • Medical devices
    As the regulatory field varies in different countries of the world, we start with classifying yo...
    Regulatory Affairs

  • Product Scope 3 Training Academy for Sourcing and Procurement Teams

    Empower your sourcing and procurement teams to drive sustainability through expert-led Scope 3 training.
    • Tailored, Expert-Led Training: Delivered virtually OR in person by SSC sustainability experts, with content customized to your company, industry, and supply chain. • Engaging and ...
    Scope 3 Training Academy for Sourcing and Procurement Teams

  • Product Scope 3 Training Academy for Suppliers

    SSC’s Scope 3 Training Academy offers comprehensive, instructor-led training to help suppliers measure, report, and reduce their greenhouse gas emissions while supporting your company’s sustainability goals.
    • Live Expert-Led Training for Suppliers: A dedicated SSC sustainability expert deliver...
    Scope 3 Training Academy for Suppliers

  • Product Life Cycle Assessment and Product Carbon Footprint

    Life Cycle Assessment (LCA) serves as a basis for developing a baseline of environmental impacts, identifying environmental hotspots, and as a decision-making tool to enhance the new product development process. 
    A Product Carbon Footprint (PCF) utilizes LCA methodology to quantify...
    Life Cycle Assessment and Product Carbon Footprint

  • Product Validation

    Our team of experts will prepare necessary protocols incorporating all critical parameters


    Process Validation:

    PharmEng professionals possess experience in validating pharmaceutical and biopharmaceutical manufacturing processes. Our team of experts will prepare necessary protocols i...
    Validation

  • Product Drug Registration

    Regulatory Service Provider
    Drug Registration

  • Product License Holding Service

    License holding service for Drug in SEA
    License Holding Service

  • Product Import Handling and Distribution

    Import Handling and Distribution service in SEA countries
    Import Handling and Distribution

  • Product Regulatory Support

    Zenovel has a highly experienced team of experts who have a complete understanding of the complete requirements of Pharma Regulatory affairs throughout the drug life cycle. Our experts have experience in directly corresponding with Pharma regulatory authorities for various segments.
    ...
    Regulatory Support
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