Regulatory affairs
Do you have any project or a study that requires experienced regulatory professionals urgently? If so, we might be able to help.
Our regulatory affairs services provides you with the option outsourcing services offer companies the opportunity to outsource entire departments with the added benefit of an effective project management structure.
BlackSwan regulatory expertise enables us to design an outsourcing plan that fulfils the company’s individual needs and is tailored to its business objectives, strategy and future vision.
How we can help:
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In alignment with global regulatory strategies, assisting in the development and implementation of regional regulatory strategies
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Supporting strategies for, coordinates the execution of, and ensures the proper archival of regulatory submissions
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Providing regulatory support for country specific Early Access Programs (EAPs). This may also include the preparation of supportive regulatory documents for these programs
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Collaborating with project teams and other internal and external key stakeholders as appropriate to ensure effective local product registrations
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Ensuring that drug products distributed with the region meet local regulatory
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Contributing to the organisational design of the regulatory affairs function and contributes to the selection of resources required to meet departmental and corporate objectives
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Supporting the co-ordination of contracted activities for translation, submission of regulatory documentation