Consultancy
POM to P
AHA was expressly set up to offer
consultancy for reclassification of products from prescription
only status to P or GSL status. AHA personnel have been
involved in POM to P switching since the first switch
in 1983 in which they were actively involved, and have
continued their activity with the majority of product
switches to date. With a vast amount of experience,
unrivalled in the marketplace, AHA is continuing to
perform at the cutting edge of the switch process. With
the introduction of new switching regulations, AHA is
liaising with the relevant industry bodies to ensure
that the new processes make continuing POM to P switches
as accessible to the pharmaceutical industry, and to
the consumer, as possible.
Regulatory Affairs
The POM to P switch process involves
a dossier submission to the MHRA, and our regulatory
affairs consultants are experts in this field. This
experience includes time spent working with the MCA
(now MHRA), developing the original POM to P rules in
1992 and more recently assisting with the revised guidelines
in April 2002. AHA also have a good knowledge of the
food supplement, herbal medicine and medical device
sector and the regulations applying to these areas.
Furthermore, AHA’s experience now encompasses
the preparation and submission of European Dossiers
in all of the above areas.
Acquisitions and Product Brokering
AHA is closely linked with a number
of companies across the pharmaceutical and herbal medicines
industry, which provides numerous networking opportunities.
AHA is well placed to access products for start-up companies
or those who want to extend their portfolio within the
prescription or OTC arena. AHA also negotiates with
potential partners in joint venture or strategic alliance
situations as an independent third party. |
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