Lebelpharma
Lebelpharma Inc. is a pharmaceutical consulting firm founded in 2008 by Ms. Nathalie Lebel, offering services in regulatory affairs, quality assurance & control, pharmacovigilance, cannabis regulations, and training. The company aims to provide high-quality consulting services at competitive prices to pharmaceutical and parapharmaceutical companies of all sizes.
Industries
Nr. of Employees
small (1-50)
Lebelpharma
Services
Consulting services to prepare regulatory submissions, assess formulations, author and review labelling, develop market-entry strategies and prepare establishment and product licence applications.
Support for QA/QC systems including SOP and master file creation, production record review and approval, product release, stability study management, visual inspections and supplier audits.
Safety surveillance services including intake and assessment of adverse events, literature monitoring, annual summaries and signal detection activities.
Preparation of cannabis licence applications, development of cannabis-specific SOPs and provision of quality assurance responsible-person services and inspection accompaniment.
Training courses on Good Manufacturing Practices (GMP), Good Pharmacovigilance Practices (GVP) and Good Production Practices (GPP).
Consulting services to prepare regulatory submissions, assess formulations, author and review labelling, develop market-entry strategies and prepare establishment and product licence applications.
Support for QA/QC systems including SOP and master file creation, production record review and approval, product release, stability study management, visual inspections and supplier audits.
Safety surveillance services including intake and assessment of adverse events, literature monitoring, annual summaries and signal detection activities.
Preparation of cannabis licence applications, development of cannabis-specific SOPs and provision of quality assurance responsible-person services and inspection accompaniment.
Training courses on Good Manufacturing Practices (GMP), Good Pharmacovigilance Practices (GVP) and Good Production Practices (GPP).
Expertise Areas
- Regulatory affairs and licence applications
- Quality assurance and quality control systems
- Pharmacovigilance and drug safety surveillance
- Cannabis regulatory compliance
Key Technologies
- Regulatory submission documentation and dossier preparation
- Adverse event reporting and signal detection methodologies
- Stability study protocols and shelf-life assessment
- Sampling and analytical testing of packaging materials
News & Updates
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