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Acquisition of Divestment Products:
Blackrock Pharmaceuticals aims to become a trusted outlet for pharmaceutical companies wishing to divest a portion of their product portfolio. The company has the experience in personnel and infrastructure to ensure that acquired product licenses are maintained in compliance with the regulations.
Good Manufacturing Practice Quality Systems play an integral part in the lifecycle of any product. Blackrock Pharmaceuticals has established a Quality Management System to ensure that products within our portfolio remain compliant with the applicable regulations. You can be assured that your branded product will continue to be maintained to the highest quality standards after transfer of the product license:
License maintenance and compliance activities
- License renewals and variations
- Periodic Safety Update Reports (PSUR’s)
- Marketing authorisation due diligence
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Product Maintenance Activities
- Pharmacovigilance activities
- Medical Information services
- Product Quality assessments
- Supplier chain audits and due diligence
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Marketing Authorisation Holder Services:
Blackrock Pharmaceuticals is registered in the UK and is able to act as the Marketing Authorisation Holder for companies wishing to market their products in the European Economic Area. We have access to regulatory affiliate partners in all European markets and can provide Pharmacovigilance, Medical Information and Qualified Person batch release services for the EU.
Outsourcing of Marketing Authorisation Holder Responsibilities:
Blackrock Pharmaceuticals can provide a service to perform all activities and responsibilities on behalf of the Marketing Authorisation Holder without being the Marketing Authorisation Holder for that product. We recognise that in today’s competitive pharmaceutical and healthcare sectors, personnel headcount is a major factor in maintaining the competitive advantage. Through our partners and alliances, we are able to manage all the responsibilities for which the Marketing Authorisation Holder is accountable. This allows your company to maintain its focus on the next blockbuster in the pipeline.
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