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Specific Services

If you need to respond to a specific requirement of your Surveillance Program, we can provide you with the following services:

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Management of Adverse Event and Incident reports

To facilitate the process related to the management of adverse events and incidents reports, we give you all the support to capture and process the cases received by the different sources, ensuring they are captured and reported within the times established in procedures and according to the current local regulations

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Monitoring Scientific Literature and Health Alerts

We identify and evaluate the publications that can potentially be a source of reports of adverse events and incidents of your company’s pharmaceutical products. We also help you with the periodic review of health alerts from the reference agencies.

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Signal Management of Products

We assist you in detecting, validating, and evaluating the signals of your company’s pharmaceutical products and we help you identifying the measures to minimize the risks identified.

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Preparation of Risk Management Plans

We have an expert team in the preparation, review, presentation of Risk Management Plans before the regulatory authority throughout its different stages: characterizing the safety prole of the medicines, planning activities to identify risks, generating and implementing risk minimization measures.

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Preparation of Periodic Safety Reports (PSUR/PBRER)

Pharmaceutical companies have the great responsibility of evaluating and analyzing the safety, efficacy and effectiveness of all the products that they commercialize in the Colombian territory and in other countries, through periodic safety reports. We understand that it is a very demanding activity and that is why we want to give the support you require to prepare and review these periodic security reports.

At SafePharma we are here to accompany you in your pharmaceutical and pharmacological processes, contact us and one of our professionals will contact you shortly.

If you need another service, contact us and we will build it together!

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