PharmaContext offers services in the areas of drug approval, quality assurance, market access, pharmacovigilance, pharmaceutical advertising, and reimbursement. It supports customers in the successful implementation of their projects in the pharmaceutical sector and provides training and consulting in these areas. The company's core activity is providing services to the pharmaceutical industry, particularly in Switzerland.
Medicinal product authorisation in Switzerland, new approvals, maintenance of existing authorisations, approval strategy, eCTD/eDok submissions, launch preparation and support throughout Swissmedic procedures.
Quality assurance
Quality assurance for pharmaceutical companies, setup and maintenance of the quality assurance system, assumption of the FvP, inspections, operating licences, audits, batch release as well as management of complaints, returns and destruction.
Market access
Market access for pharmaceutical products in Switzerland, setup of a branch, company headquarters formation, support with operating licensing, submission for authorisation and long-term support after market launch.
Pharmacovigilance
Pharmacovigilance for Swiss pharma companies, reporting adverse drug reactions, literature screening, safety reports, risk management and assumption of the PV responsible person.
Medicinal product advertising
Medicinal product advertising with expert review of promotional materials, compliance checks, ensuring compliance with Swissmedic, HMG and advertising requirements, as well as assumption of the advertising responsible person.
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