APCER PHARMA
APCER PHARMA is a front-end solution provider offering an integrated platform of pharmacovigilance and regulatory services to pharmaceutical companies throughout the world.
Our unique proposition is based on a compelling portfolio of products and services, an extremely high level of quality consciousness, a competitive cost structure, and proven and experienced management team.
APCER have a team of Pharmacovigilance experts who can provide a complete range of services using the latest state of the art technology.
The services we offer include:
- The establishment of US and EU-Regulatory compliant Pharmacovigilance systems. We have invested in an infrastructure that means we can operate as the US or EU hub for our clients.
- Reporting of Individual Case Safety Reports / 7- and 15-day MedWatch alerts.
- PSUR / Periodic Report submission We can manage the complete process for compilation and submission of Periodic Reports / Periodic Safety Update Reports including generation of literature searches, compilation of expert reports, sign off of the periodic report / PSURs by a medically qualified person and submission to FDA / EU-Regulatory agencies.
More importantly all of these services can be offered on an ad-hoc or contracted basis to complement the resources you have in your organisation, we can enhance or help out in times when you are overloaded., or take over the complete Pharmacovigilance function.
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Company details
- Safety/Pharmacovigilance services
- Regulatory strategy and operations
- QP Services
- Marketing Authorisation; maintenance, variations, renewals, transfers.
- Health Authority Interactions
- Full Pharmacovigilance Support
- Full Pharmacovigilance Services
- Full Regulatory Services
- Marketing in CIS
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