Hericon AB Mobile E-mail
+46 705 473 345 she@hericon.se
Hericon AB
Hedman Ericsaeter Regulatory Intelligence Consulting
Services
Benefit from our services
Comprehensive knowledge and broad experience in managing all the work within the areas Regulatory Affairs, Quality Assurance and Pharmacovigilance, control of the rules and guidelines and maintaining the status of the work in countries in Nordic area, Benelux and Poland.
Our Services
Regulatory Affairs Regulatory Intelligence and Strategies
Quality Assurance and Compliance across the business.
Pharmaco vigilance
Responsible Pharmacist
Regulatory Affairs
Providing Regulatory Intelligence and Strategic planning. Operational Regulatory affairs activities, submissions to authorities and maintainance, handling of labelling information, communication with authorities and ensuring conformance to national and EU laws.
Assistance for market entrance for pharmaceuticals and food supplements
Quality Assurance
Running, developing and implementing Quality Management System including writing SOPs, WIs, enclosures and training of staff. Further examples are handling of change controls and product quality related matters, quality risk management, CAPAs, audits/inspections, deviation management. Planning and execute Management reviews with leadership teams. Development of Dawn Raid guideline.
Pharmacovigilance
Operational Pharmacovigilance activities.
Customer complaint activities. Pharmacovigilance training of staf.
Responsible Pharmacist
Responsible pharmacist for wholesales licenses.