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:
01
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
02
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
03
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
04
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
05
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
06
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
07
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
08
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
09
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
10
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
