Pharma IT focus on delivering services and consultancy related to business and IT within the Pharmaceutical Industry. We focus on quality and set high standards for ourselves.
Our identity is to be agile and competitive, we only engage with the best – our consultants are skilled and professional, having many years of experience within Pharma and IT.
Pharma IT offer services and consultancy within the following area’s/domain’s:
|Project, Program and Service Delivery Management||Regulatory Operations||Pharmacovigilance *NEW|
|Our Program and Project Management consultants have several years of experience in delivering successful program and projects within the pharmaceutical industry and business domains.|
We hold certifications within:
|We have experience in delivering IT solutions to support the Regulatory Affairs business processes:|
The Pharma Industry must comply with the requirements to report in ISO IDMP format. We are tracking the latest development in respect to the IDMP reporting requirements and have knowledge in the available options to become IDMP compliant pending on your size and needs.
|Companies are experiencing an increase in number of ICSRs and with new requirements from authorities support in daily work and optimization of existing working processes are needed.|
Our consultants are experienced within:
IT Quality, Compliance and Security Management
|Supply Chain / Serialization|
Business Quality and Compliance Management
|Our IT Quality and Compliance Consultants are specialists in implementing compliant and secure IT systems from any 3rd party vendor. We are experienced in delivering risk based GAMP compliant project implementations:|
We hold certifications within Certified in CISSP (IT security), ISO27001, CISA (Information System Audit), CISM (Security Manager), GxP, Computerized System Validation, Data Integrity, ALCOA principles, 21 CFR Part 11 / EU Annex 11
|We have several Serialisation experts who have been part of implementing systems to handle serialisation in major Pharmaceutical companies.|
We have implemented solutions for, China, South Korea, US and Saudi Arabia, and are familiar with the EU Delegated act.
We can cover the following areas within Serialisation:
|Our Business Quality and Compliance Consultants can support and QA and QC activity being part of the daily business within a Pharmaceutical Department:|
We hold certifications within Quality Risk Management, Lead Auditor and Audit Management as well as GDPR
Should you be interested in getting more information please contact us here