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From initial stages through authorization
Our team is adeptly equipped to support the development of medicines, covering the entire spectrum from the initial stages of development through authorization and extending to the end of the product's lifecycle. Their proficiency spans the entire lifecycle, ensuring comprehensive support at every crucial phase of medicine development.
Clinical Trial Regulation
The Clinical Trial Regulation (CTR) is the recently enacted EU regulation that supersedes 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 goal of the Clinical Trial Regulation (CTR) is to standardize and harmonize clinical trials conducted within the European Union (EU). This objective is reinforced by the introduction of a new system, the Clinical Trials Information System (CTIS). Another key aim of the CTR is to enhance the transparency of information related to EU clinical trials, as evidenced by significant changes to data publication and availability. This aligns with the broader objective of promoting transparency in the conduct of clinical trials within the EU.
We can support you with:
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Dossier Preparation
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EU Operations Structure
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SOP Updates
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Gap Analysis
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Transition and Submission Strategy
MarketingAuthorisation
Our team has a wealth of experience in providing successful support for global Marketing Authorisation Applications, offering assistance from pre-submission interactions all the way through to the approval of the product. We offer a comprehensive range of support services, ranging from strategic advice and document review to full authoring and publishing of submissions and responses. Whether you represent a major pharmaceutical company or a small biotech firm planning to register your inaugural product in the US, UK, EU, or any other region worldwide, our team possesses the capabilities to assist you in successfully bringing your product to market.
We can support you with:
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EU Marketing Authorisation Application (MAA)
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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. Our team collaborates with our clients on various aspects of post-licensing activities, encompassing compliance activities as well as the development of detailed strategies for line extensions and new indications. This partnership extends across the entire life cycle of a product, aiming to optimize its performance and contribute to sustained success in the market.
We can support you with:
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Post-marketing Variations
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Transfer of Ownership and Divestment
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Regulatory Compliance
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Transfer of Ownership and Divestment
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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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