What We Do
Regulatory Submissions in UK
· 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
Pharmacovigilance
· 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
Pharmaceutical Services
· Audits
· Due Diligence of MAs
· Translations
· CTD/eCTD Dossier Preparations
· Holding MAs for companies
· Knowledge of EU legislation
· Labeling advice and preparation
Contact Us
Have Questions?
Please reach out to us with any concerns or special requests.
Feel free to send any documents to info@mlchive.com.
Multiple Links
4 Pond Green, Manor, Ruislip, HA4 6EW, United Kingdom
Phone: +44-7515118739 Email: info@mlchive.com
Hours
Monday - Friday: Closed
Saturday - Sunday: 9am - 5pm
Multiple Links
4 Pond Green, Ruislip, HA4 6EW, London, United Kingdom.
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