Baupharma
Baupharma is a trusted pharmaceutical service provider based in Prague, with 25 years of industry experience. They offer a comprehensive range of services including pharmacovigilance, regulatory affairs, medical writing, batch release & distribution, translations, and clinical research. With a global reach covering over 60 countries and offices in four regions, Baupharma is committed to building trust in pharmaceutical excellence through integrity, innovation, and collaboration. They serve clients across diverse markets worldwide and emphasize quality, client satisfaction, and continuous growth.
Industries
Nr. of Employees
small (1-50)
Baupharma
Prague, Hlavni mesto Praha, Czech Republic, Europe
Services
Outsourced pharmacovigilance activities including case processing, safety reporting, signal detection and PSMF support.
Regulatory dossier preparation, market authorisation submissions and country-specific registration support.
Authoring of clinical and regulatory documents such as protocols, clinical study reports and submission modules.
Coordination of batch release activities and distribution support to facilitate product movement and regulatory-compliant release.
Regulatory and medical translation of submission, safety and clinical documents into local languages.
Operational support for clinical trials including study start-up, site coordination and monitoring activities.
Outsourced pharmacovigilance activities including case processing, safety reporting, signal detection and PSMF support.
Regulatory dossier preparation, market authorisation submissions and country-specific registration support.
Authoring of clinical and regulatory documents such as protocols, clinical study reports and submission modules.
Coordination of batch release activities and distribution support to facilitate product movement and regulatory-compliant release.
Regulatory and medical translation of submission, safety and clinical documents into local languages.
Operational support for clinical trials including study start-up, site coordination and monitoring activities.
Expertise Areas
- Pharmacovigilance and safety surveillance
- Regulatory affairs and product registration
- Clinical trial management
- Medical writing and regulatory documentation
Key Technologies
- Pharmacovigilance databases and safety reporting systems
- Clinical trial management systems (CTMS)
- Electronic regulatory submission formats (e.g., eCTD-like workflows)
- Document authoring and medical writing workflows
News & Updates
EMA’s safety committee (PRAC) has decided on stopping the temporary restriction of people aged 65 years or older from getting the Ixchiq vaccine.
The FDA gave accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals, Inc.), a targeted therapy for advanced multiple myeloma.
The Saudi Food & Drug Authority (SFDA) is actively working towards advancing public health through strategic initiatives, including endorsing real-time brain stimulation technology for Parkinson’s disease.
Recent FDA findings indicate that extended-release stimulants for ADHD in children below 6 years old can cause weight loss.
Regulations related to radioactive substances or ionizing radiation in clinical trials have been updated to ease application processes.
Serplulimab, an anti-PD-1 antibody, has been approved by the UK’s MHRA for extensive stage small cell lung cancer.
EMA’s safety committee (PRAC) has decided on stopping the temporary restriction of people aged 65 years or older from getting the Ixchiq vaccine.
The FDA gave accelerated approval to linvoseltamab-gcpt (Lynozyfic, Regeneron Pharmaceuticals, Inc.), a targeted therapy for advanced multiple myeloma.
The Saudi Food & Drug Authority (SFDA) is actively working towards advancing public health through strategic initiatives, including endorsing real-time brain stimulation technology for Parkinson’s disease.
Recent FDA findings indicate that extended-release stimulants for ADHD in children below 6 years old can cause weight loss.
Regulations related to radioactive substances or ionizing radiation in clinical trials have been updated to ease application processes.
Serplulimab, an anti-PD-1 antibody, has been approved by the UK’s MHRA for extensive stage small cell lung cancer.