Bellatriks Consulting is a high-end consultancy house headquartered in Copenhagen, focusing specifically on the pharmaceutical and life science industry. We strive to deliver experienced resources directly to support our clients in the area of Pharma IT & Automation, Project Management, GMP, GDP and Validation.
Working with clients both national and internationally, our core value is never to compromise and always to deliver. Since the establishment in 2015, we have expanded quickly and with more than double a lifetime of combined knowledge, our employees are ready to assist in all areas of our clientâ€™s production chain and projects.
QA and Validation
Tel.: +45 53838436 e-mail: email@example.com
Tel.: +45 53838475 e-mail: firstname.lastname@example.org
Tel.: +45 60201912 e-mail: email@example.com
Consultancy on Technical solution of Pharma It
Implementation of Parexel Insights and Aris Global Register
Writing and reviewing Technical Design Specifications
Code Review in Java, PL/SQL, Java Script, C#
Configuration Management Strategy
Assessment of new IT application
We can support you e.g.:
Fast track project management, revamps of plants within the pharmaceutical and confectionary area in close cooperation with manufacturing and R&D.
Turn key project management within the pharmaceutical industry.
Facilitating project workshops and design reviews to ensure that all requirements are met for all stakeholders.
Prepare for an FDA or EU GMP Inspection, perform Internal Audit.
Implementing Quality Management System for Medical Device company
Perform Supplier Audit or Quality Assessment at CMO on behaft of the client.
Support your QA organisation with QP/QA tasks regarding review of Batch Record, APR/PQR
Perform validation tasks in Cleaning / Sterilization / Transport processes.
Perform Computer Systems Validation acc. to GAMP 5, FDA 21 CFR Part 11 and EU GMP Vol. IV Annex 11.
Writing Validation Master Plan, Validation Master Plan Report, Validation Plan, Validation Plan Report etc.
Writing SOP's, Non Conformities (deviations), Incl. Root Cause Analysis
Writing Stability protocols/Reports
Mapping Temperature of warehouses and cold rooms.
Giving on-site GMP, GDP and Validation Training/Workshop to the Pharmaceutical, Medical Device companies.
Support your company to establish Medical Device Quality System and implement ISO 13485, Medical Device Directive (93/42/EEC).