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● Feasibility; market orientation

   and  competitive positioning

   reports Regulatory impact       

● Registration strategy

● MC Pharma is a pre-

    registration contract

    Applicant/Prospective Holder

    of the Certificate of

● Portfolio includes: NCE’s,  


   Medicines, Biologicals,

   Biosimilars, Veterinary 

   Medicines and

   Complementary medicine
● Due diligence on registration 
● Dossier compilation: CTD /

● 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

● Robust Quality Management

● 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

● Design, certification and

   approval of printed packaging

● 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

● Established relationships with 
   wholesalers (34) and

   distribution (4) 

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