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.