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Comprehensive life cycle support & development strategies
Leveraging a profound comprehension of medical device regulatory and quality prerequisites, our consultants collaborate with companies and manufacturers. We offer comprehensive life cycle support and product development strategies, ensuring successful market placement of devices.
Clinical Trial Regulation
The Clinical Trial Regulation (CTR) is the recently implemented EU regulation, supplanting the existing Clinical Trial Directive (CTD). It officially came into effect on January 31, 2022, and became obligatory for all new trials starting from January 31, 2023. Ongoing trials are required to complete their transition to comply with the CTR by January 2025. The primary objective of the Clinical Trial Regulation (CTR) is to standardize and harmonize clinical trials conducted within the European Union (EU). This goal is reinforced by the introduction of a new system known as the Clinical Trials Information System (CTIS). Another key aim of the CTR is to enhance the transparency of information related to EU clinical trials. This is evident in the substantial changes made to data publication and availability, aligning with the broader objective of promoting transparency in the conduct of clinical trials within the EU. Our expertise enables us to operate effectively under the CTR with confidence, assisting you in navigating the regulatory landscape and meeting the standards set forth by the updated regulation.
We can support you with:
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EU Operations Structure
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Transition and Submission Strategy
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Gap Analysis
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Dossier Preparation
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SOP Updates
Market Authorization
Our team has amassed extensive experience in providing successful support for global Marketing Authorization Applications, offering assistance from pre-submission interactions all the way through to the approval of the product. We offer a diverse range of support services, including strategic advice, document review, and full authoring and publishing of submissions and responses. Whether you represent a large pharmaceutical company or a small biotech firm embarking on the registration of your inaugural product in the US, UK, EU, or any other region worldwide, MY Pharma has the capabilities to assist you in successfully bringing your product to market.
We can support your team with:
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New Drug Application (NDA) /Biologics License Application (BLA)/ Abbreviated New Drug Application (ANDA)
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Pre-submission Meetings
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Oral Explanations
Post Licensing
We recognize the significance of life cycle management in ensuring the success of a product. DLRC collaborates with our clients on all aspects of post-licensing activities, encompassing compliance activities, as well as the development of detailed strategies for line extensions and new indications. Our partnership extends across the entire life cycle of a product to optimize its performance and contribute to its sustained success in the market.
We can support you with:
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Regulatory Compliance
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Post-marketing Variations
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Line Extensions
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About
About MY Pharma Consulting
MY Pharma Consulting offers regulatory affairs, pharmacovigilance, compliance, and quality services aimed at assisting pharmaceutical and biotechnology firms in navigating the complex regulated landscape. We support our clients with acquiring and upholding medicinal product licenses throughout every phase of a product's existence.
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