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The European Clinical Trials Directive requires that before a clinical trial can commence in a Member State of the EU, a request for authorization to conduct a clinical trial must be submitted to the competent authority of the Member State(s) concerned and approval must be obtained from the relevant Ethics Committee(s). The Directive applies to all interventional trials with medicinal products/drugs in Phase I – IV

RegPak BioPharma Consulting
specializes in regulatory affairs consulting services relating to pharma and biological products and has focused in this field for over 10 years. It has assisted clients from Europe, the United States, Australia and India for their innovative product development. This extensive experience, with a proven track record, places RegPak BioPharma Consulting in an unrivalled position as consulting firm in this specialized field and provides a level of expertise from which all clients can benefit.

The types of products on which RegPak BioPharma Consulting have consulted includes Biologics, Biosimilars, New Chemical entities, Generics, Herbal Medicinal Products, Food Supplements and Medical Devices. Some of these were products in early development; other activities were at the submission stage. RegPak BioPharma Consulting were also involved in supporting clients during the response phase to health authority questions and objections.

RegPak BioPharma Consulting applies its expertise in a practical and logical way to help companies worldwide. We continually strive for innovation and we share our principles and practices through training, presenting, and publishing. We develop services and creative offerings that provide new and more efficient ways for our customers and their vendors, suppliers, and service providers to conduct their business both within regulatory compliance and with reduced risk. We are prepared to achieve the same results for you.

Needless to say, RegPak BioPharma Consulting’s approach has always been interdisciplinary, with a strong emphasis on the science underlying the product.

 
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