EU GDPR - Data protection Officer - Life Sciences - Quality and IT Audits - US Privacy Shield - Legal Representative - Regulatory - Clinical Data Management - Inspection Readiness - Computerised System Validation - Clinical Data Management Best Practices
The March 2024 Free GCP GDPR Life Sciences Newsletter has been issued! Subscribe Now: write to: contact(at)pharmarketing.net
Read about Data Altruism and Data Sharing under the new EU Regulatory Landscape of the Data Governance Act and the European Health Data Space, and the interplay with GDPR and Guidelines from Clinical Research!
Data Protection Services
* EU GDPR Compliance Services
* Legal Representative for EU GDPR and Clinical Trials
* External Part-Time Data Protection Officers (DPOs) in all EU
* US Privacy Shield Compliance Services
* Data Protection Impact Assessments (Article 35) e.g. for your next clinical or observational studies
* Review of Contracts, ICFs, Protocol, etc.
Audits, Computerised System Validation and Inspection Readiness
* Audits of your sub-contractors
* Audit of target company for M&A
* Audits on IT, QA, CSV and Data Protection
* General IT Audit
* Detailed IT Audit
* IT Hacking tests
* Compliance with IT Security Good Practices and ISO 27001
* Computerised System Validation (GAMP5)
* Inspection Readiness (GxP, ISO, CFR21 Part11...)
Training Centre
* Data Protection Trainings
* Security Trainings
* IT Best Practice Trainings
* In House trainings - onsite or via web conference
* Training of Project Teams
* Training of End Users
* Development of ad-hoc trainings
EU Legal Representation
Legal EU Representation for:
* Clinical Trials
* Orphan Drug Designation
* SME
* GDPR
OUR CUSTOMERS
PHARMARKETING
is an operational consulting company based in France and acting in Europe, America, Asia and Africa.
We help life sciences companies to become compliant with European General Data Privacy Regulation (GDPR), with US Privacy Shield, Good Clinical Practices (GCP) and IT Good Practices (GAMP, ISO 27001), and to become ready for inspections from healthcare authorities.
We also provide Legal Representation in the EU and UK for Clinical Research and GDPR.
We deliver Audits of Clinical Operations, IT systems, business processes, and Quality Compliance. We also perform Computer System Validation.
Our Data Protection Officer associates are based in all major European countries: they are experienced professionals in the life sciences industry, clinical studies, safety, data management and regulatory.
See some of the team members on the right.
MEMBER OF 4 ASSOCIATIONS
