Clinical Trial Support

We have a team of Regulatory Affairs Experts with experience in the development of new therapeutic products and the Regulatory processes to be followed to place medicinal products on the market across the globe.

Our Regulatory Experts Can Support:

The Development of Appropriate Regulatory Filing Pathways

Interpret the Legal and Regulatory Landscape

The Design of Interventional and Non-Interventional Studies

Preparation of Clinical Trial Agreements, Investigational Medicinal Product Dossiers, and Investigational New Drug Applications for Clinical Trials

Preparation of Marketing Authorisation Applications and New Drug Applications to Support Medicinal Product Licensing

Interactions with Regulatory Authorities

Development of Drug Master Files

Authoring of Common Technical Dossier Documentation to Support the Registration of New Medicines

Preparation of Internal Standard Operating Procedures and Work Instructions

Development of appropriate regulatory filing pathways

LS Law specialises in crafting tailored regulatory filing pathways for clinical trials. We work closely with clients to navigate regulatory requirements efficiently, ensuring timely submissions and compliance with all relevant regulations.

Interpretation of the legal and regulatory landscape

Our team provides expert interpretation of the legal and regulatory landscape governing clinical trials. We stay updated on evolving regulations to offer clients accurate guidance, enabling them to make informed decisions and mitigate compliance risks effectively.

Design of interventional and non-interventional studies

LS Law provides comprehensive support in designing both interventional and non-interventional clinical studies. We collaborate closely with clients to develop robust study protocols, informed consent forms, and other essential documentation, ensuring adherence to regulatory standards and ethical considerations.

Preparation of Clinical Trial Agreements, Investigational Medicinal Product Dossiers, and Investigational New Drug applications

LS Law assists clients in preparing essential documents for clinical trials, including Clinical Trial Agreements, Investigational Medicinal Product Dossiers, and Investigational New Drug applications. Our meticulous approach ensures compliance with regulatory requirements and facilitates smooth trial initiation.

Preparation of marketing authorisation applications and new drug applications

We offer comprehensive support in preparing marketing authorisation applications and new drug applications to support the licensing of medicinal products. LS Law ensures accuracy and completeness in document preparation, optimising the chances of regulatory approval.

Interactions with regulatory authorities

LS Law facilitates interactions with regulatory authorities throughout the clinical trial process. We handle communications, submissions, and meetings on behalf of clients, ensuring effective dialogue and resolution of regulatory issues.

Development of drug master files

Our team supports clients in developing and maintaining drug master files to provide comprehensive information on pharmaceutical ingredients. We ensure all drug master files comply with regulatory requirements and facilitate their submission to regulatory authorities as needed.

Authoring of Common Technical Dossier documentation

LS Law assists clients in authoring the Common Technical Dossier documentation required for the registration of new medicines. We ensure the completeness and compliance of submissions, facilitating regulatory approval.

Preparation of internal standard operating procedures

We help clients develop internal standard operating procedures specific to clinical trial operations. Our tailored SOPs provide clear guidance for personnel, promoting consistency and compliance with regulatory requirements.

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Contact Life Science Law today to discuss how we can help supply clinical trial support

We are ready to discuss your challenges and would be delighted to help you identify an optimal solution, and a practical course of action to get you there.

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Supporting You in this Evolving Area Through Our Team of Regulatory Experts