● Feasibility; market orientation
and competitive positioning
reports Regulatory impact
assessment
● Registration strategy
● MC Pharma is a pre-
registration contract
Applicant/Prospective Holder
of the Certificate of
Registration
● Portfolio includes: NCE’s,
Generics/Multisource
Medicines, Biologicals,
Biosimilars, Veterinary
Medicines and
Complementary medicine
● Due diligence on registration
documentation
● Dossier compilation: CTD /
eCTD
● Package inserts, patient
information leaflets, label
compilation and review
● Compilation of Standard
Operating Procedures, Site
Master Files and Licence
applications, where required
● MC Pharma acts as the Holder
of Certificates of Registration
(HCR) for registered
medicines.
● Robust Quality Management
System
● Finished Product Release
● Responsibility
● Product Quality monitoring
and Reviews
● Dossier
amendments/variations and
life-cycle management
● Quality audits; GMP
compliance; Self-Inspections
& 3rd Party Compliance
Audits
● Design, certification and
approval of printed packaging
materials
● Pharmacovigilance
● Post-Marketing surveillance
● Trained and specialised sales
force with a national footprint
● Training of Representatives
according to the Marketing
Code and Regulations
● Compliance certification of
adverts and marketing aids
● In-house marketing service
● Sales data recording and
analysis.
● Established relationships with
wholesalers (34) and
distribution (4)
facilities