Pharma IT Services

PharmaIT focus on delivering services and consultancy related to business processes and IT within the Pharmaceutical Industry. We focus on Quality and set High Standards for our self.

Our identity is to be small, agile and competitive, We only engage with the best – our consultants are Experienced and Professional, having many years of experience within Pharma and IT.

Pharma IT offer services and consultancy within the following area’s/domain’s:

Program and Project Management

Our Program and Project Management consultants have several years of experience in delivering successful program and projects within the pharmaceutical industry and business domains. Some of them are highly certified within IMPA, PMP, PRINCE2, MSP and agile methodologies (supported by GAMP5).

IDMP

By end 2017 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. 

Regulatory Affairs

We have experience in delivering IT solutions to support the Regulatory Affairs business processes:

  • Document Management
  • Submission Management
  • Regulatory Information Management Systems
  • xEVMPD reporting
  • ISO IDMP reporting
  • Records Management

Pharmacovigilance

Most companies are experiencing an increase in number of ICSRs and with new requirements for B2B R3 formats being mandatory by 2019/2020 upgrade of safety systems and optimization of existing working processes are needed. Our consultants can support you in ensuring a successful completion of these activities.

Quality and Compliance Management

Our Quality and Compliance Management Consultants are experienced within:

  • SOP Management
  • Training Management
  • Test and Validation Management 
  • Inspection Readiness
  • Audit Management

Serialization

The pharma industry is required to comply with serialization requirements worldwide. Pharmaceutical manufacturers will be responsible for storing and reporting serialization data from production until outbound delivery to a customer destination. We have experience in implementing IT systems that comply with the regulatory requirements.

Should you be interested in getting more information please contact us here

About the author

JakobJuulRasmussen
Jakob Juul Rasmussen

IT Program/Project Manager with 16 years of experience within the pharmaceutical industry, finance and the public sector. Experience with infrastructure, service delivery management, application development, SOA and SAP projects

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