Pharma Consulting
We help life sciences companies, raise the bar for excellence. To help identify business goals and help clients achieve the most profitable results in a safe and compliant way. Novatek can be your partner of choice for the pharmaceutical, biotechnology and medical device teams, with integrity, professionalism and proven capabilities to provide the solutions you need.
Inspection & audit findings
Regulatory inspection support, preparation for, hosting of and resolution of observations. Pharmaceutical supplier auditing, qualified person declarations, oversight and qualification.
GMP & GDP improvements
Pharmaceutical quality management system, review, optimisation and automation.
Computer system validation training, qualification and support.
Training
Training, GMP, GDP, QP, RP, CSV, auditor whatever you need for your pharmaceutical business we can deliver.
Process improvements
Automation of systems and processes to enhance performance, efficiency and integration.
Consulting
Regulatory compliance advice and structure support when your organisation needs it.
Site licence support
Assistance in the preparation and application for a new site licence (MIA).
Inspection support
Support when preparing for a regulatory inspection.
Audit ready support
Help in attaining and maintaining an audit ready state to eliminate the last minute confusion prior to inspection.
General advice
Advice on issues such as good manufacturing practice, regulatory compliance, contract manufacture, cold chain, import, active pharmaceutical ingredients and subcontracting.
Supplier auditing support
Supplier auditing; API, excipient, contractors and suppliers.
Qualified Person batch release of manufactured and imported products.
Pharmaceutical Quality System support
Creation, maintenance and update of your pharmaceutical quality system for your manufacturing, supply and distribution of medicinal products.
