Get Brochure

SERVICES

Regulatory Services in New Zealand

Regulatory Compliance Experts in New Zealand

MedSafe is the Medicines and Medical Devices Safety Authority of New Zealand that regulates therapeutic products, ensuring their quality, efficacy, and safety prior to distribution within the country. All medicinal products and medical devices in New Zealand must be approved and registered with Medsafe unless exempted.

The regulatory process of New Zealand includes:

  • pre-market assessment,
  • post-market monitoring, and
  • enforcement of standards.

Why Choose DDReg for Regulatory Services in New Zealand?

The regulatory landscape in New Zealand can be challenging due to Medsafe's specific requirements for the approval and registration of medicinal products and medical device services. At DDReg, we provide end-to-end services and tailored support to global pharmaceutical companies to help them meet these regulatory requirements and successfully bring their products to the New Zealand market, with zero risk of non-compliance. Our services include:

  • Guidance on pre-market assessment and registration processes
  • Support for post-market monitoring and compliance
  • Assistance with GMP inspections and maintaining manufacturing standards
  • Advisory services for meeting Medsafe's guidelines and regulations
  • Collaboration with MAAC and other regulatory bodies

    Partner with DDReg to ensure your products meet New Zealand's regulatory standards and achieve successful market entry.

    Our Regulatory Affairs Consulting Services in New Zealand portfolio covers:

    Strategies

    Regulatory Strategies / Expert Views

    Regulations pertaining to pharmaceutical products are continuously changing...

    Read More ➔
    Authorizations

    New Product Authorizations

    Pharmaceuticals and other medicinal products need to be prior authorized by...

    Read More ➔
    Analysis

    Gap Analysis and Remediation

    A gap analysis is a regulatory review process that identifies data gaps in the technical...

    Read More ➔
    delig

    Regulatory Due Diligence

    Regulatory issues arise unexpectedly and can create significant strain on a company’s...

    Read More ➔
    Authorizations

    API/DMF

    DDReg provides expert consulting and efficient services for quality Drug Substance...

    Read More ➔
    CMC

    CMC Advisory

    When it comes to regulatory strategies, CMC documentation play a crucial role in developing...

    Read More ➔
    Approval

    Post Approval Life Cycle Management

    Managing the post-approval life cycle of a product is an essential component to sustaining...

    Read More ➔
    Regulatory Certification

    Regulatory Certification

    Administrative documents are an integral component of regulatory submissions and constitute key certifications...

    Read More ➔
    Regulatory Certification

    ANDA and MA Holder Services

    The regulatory approval pathway for Abbreviated New Drug Applications (ANDAs) is relatively complex....

    Read More ➔
    Contact our experts today !
    Country Specific Services

    How can we help you?
    Call us on:+1 (302) 601-2755