RLD Australia | eCTD Australia | Regulatory affairs consultants

We specialize in providing comprehensive dossier regulatory services tailored to meet the specific needs of the pharmaceutical industry. Our services include:

Local Agent Representation:

Our team of experienced professionals has in-depth knowledge and understanding of regional specific requirements and legal obligations. We carefully assess your needs and use our expertise to develop effective strategies to maximize product success. By thoroughly evaluating each customer’s requirements, we customize our services to meet their unique needs.

Regulatory Strategy:

Our experts bring exceptional knowledge of current guidelines and extensive experience in local regulatory standards. We specialize in providing strategic regulatory advice and establishing robust regulatory strategies tailored to your needs.

Whether you’re navigating complex regulatory environments or seeking to enhance compliance efficiency, our team is dedicated to delivering tailored solutions that drive success.

Our Regulatory Strategy Services Include:

Developing a strategic regulatory framework from product development to approval and throughout life cycle management.
Advising on procedures, formats, and conducting necessary negotiations to obtain and maintain marketing authorization for pharmaceutical products.
Providing guidance on regulations and scientific requirements to assist in developing a regulatory strategy and assessing the acceptability of quality, preclinical, and clinical documentation for submission.
Offering technical advice and scientific justification.
Ensuring regulatory submissions comply with regional and local requirements.

Due Diligence:

Our experienced regulatory professionals offer specialized due diligence services designed to help you navigate new markets efficiently and effectively. Our services include:

Our Due Diligence Services Include:

Conducting gap analysis and reviewing the appropriateness of existing approved dossiers for registration in new markets to ensure compliance with regional and local requirements.
Performing gap analysis for new dossiers and anticipating queries from regulatory agencies.
Reviewing administrative information and product information specific to the target country.

Dossier Submission and Life cycle:

We specialize in providing expert assistance in preparing high-quality regulatory dossiers for submission to regulatory authorities. Our dedicated team ensures that all necessary documentation, including quality, preclinical, and clinical data, is meticulously compiled and organized in strict accordance with regulatory requirements.

We manage the compilation and organization of all required documentation, ensuring completeness and adherence to regulatory standards.
Quality Assurance: Our rigorous quality assurance processes ensure that each dossier is thoroughly reviewed and verified for accuracy and compliance before submission.
Regulatory Expertise: With deep knowledge of regulatory requirements across diverse regions, we tailor our dossier preparation to meet specific jurisdictional demands, facilitating smoother approval processes.

Lifecycle Management Support

We offer comprehensive lifecycle management support designed to assist you throughout the product lifecycle, ensuring compliance and adapting to evolving regulatory requirements. Our services include:

Variations Assessment: We assess the impact of proposed changes on your regulatory dossiers and provide strategic advice on the best approach for submission.
Variations Management: We provide guidance and assistance in managing variations to your regulatory dossiers, helping you navigate changes in product formulation, manufacturing processes, or labeling requirements.
Compliance Monitoring: We monitor regulatory changes and assess their impact on your product portfolio, proactively updating dossiers to ensure continuous compliance with local and regional regulations.
Safety updates: Updating Product Information (PI) to ensure the safety and efficacy of pharmaceutical products

Why Choose Us:

Proven Track Record: Our team has a demonstrated history of successfully preparing dossiers that meet regulatory expectations and expedite approval timelines.
Efficiency and Accuracy: We prioritize efficiency without compromising on accuracy, helping you navigate complex regulatory landscapes with confidence.

Get Started:

From initial dossier preparation to lifecycle management, our team is committed to delivering tailored regulatory solutions that ensure compliance, streamline processes, and support your business objectives.

The Medical, Legal, and Regulatory (MLR) review of Promotional Materials:

To ensure compliance with the Code and the Regulations.
Verifying the accuracy of scientific claims.
Verifying the accuracy of claims against competitors’ products.
Verifying the minimum Product Information (miniPI), Pack Inserts, Labels, FAQs.

REGULATORY SUPPORT