Multiple Links of Consultants

  · Regulatory Submissions – National/CP/DCP/MRP

· Abridged Marketing Authorisation Applications

· Variations Type I and Type II

· Marketing Authorization Management

· Technical Transfer (for GMP approval)

· GMP & SOP’s

· Artwork Generation/Design/Management

· Batch Release Management (outsourced MIA activities)

· MA Dossier Management

· Regulatory Advise & GMP/GDP Guidance

  · Standard Operating Procedures (SOPs)

· Summary of PV Systems (SPSs)

· Risk Management Plans (RMPs)

· Clinical Trial Annual Safety Reports (ASRs)

· Periodic Safety Update Reports (PSURs)

Post Marketing Pharmacovigilance

· Drug Safety Project Management

· Collection and follow-up of Adverse Drug Reactions (ADRs) originating from all post-market sources

· Weekly literature searches of Medline

· Electronic management of ADRs on the client’s proposed database

· Electronic expedited reporting to Competent Authorities

· Eudravigilance set up and management

· EU Qualified Person for PV (QPPV) and deputy QPPV 

· Reconciliation with Medical Information

· Compliance oversight

· Signal Detection

· 24 hour cover

· Receipt, logging and follow-up of medical information enquiries

· PV Audits

· PV Training

  · Audits 

· Due Diligence of MAs

· Translations

· CTD/eCTD Dossier Preparations

· Holding MAs for companies

· Knowledge of EU legislation

· Labeling advice and preparation