Cesta na Brdo 100, 1000 Ljubljana, Slovenia
phfarmed@phafarmed.com
About us
Services
Business development
Market access
Regulatory affairs
Clinical trials
In-licencing/Out-licencing
Acquisitions
Contact
Regulatory affairs
PREPARATION/SUBMISSION OF MARKETING AUTHORIZATION APPLICATIONS
National registration.
MRP/DCP/CP registration.
Human medicinal products (MPs, DCP, MRP, NP).
Veterinary medicinal products (VMPs, DCP, MRP, NP).
Medical devices.
SPECIAL MEDICINES AREAS
Innovative and generic medicinal products (including biotech),
herbal medicinal products (natural medicines),
strong vitamin and mineral products,
medicinal gasses,
radiopharmaceuticals,
food supplements,
cosmetics,
biocides,
vaccines,
homeopathic medicinal products,
blood products and plasma-derived medicinal products.
EXPERT REPORTS – PRE-AUTHORIZATION – POST-APPROVAL AND SUBMISSION SUPPORT
various applications, renewals, and notifications,
update and upgrade of documentation,
SPC, PIL, labelling in accordance with national legislation,
marketing materials review, harmonization with approved medicinal products documents,
communication with authorities (new requirements/answers to deficiency/ clarifications/permissions),
packaging materials (mock-ups/artworks) and proofreading.
PHARMACOVIGILANCE
TRANSLATION