Biopharma Institute
Biopharma Institute is dedicated to providing exceptional compliance training solutions for professionals and organizations in the pharmaceutical, clinical research, biotechnology, and medical device industries. Since 2003, it has offered a comprehensive range of online courses, seminars, and training tools to promote regulatory compliance, product safety, and professional development. Recognized globally and accredited by the BBB, the institute aims to deliver reliable, current, and effective training that supports career advancement and organizational success.
Industries
Nr. of Employees
small (1-50)
Biopharma Institute
Paramus, New Jersey, United States, North America
Patents
Variant recombinant dermatophagoides pteronyssinus type 1 allergen protein and its preparation method and application
US-11359191-B2
View DetailsRecombinant Dermatophagoides pteronyssinus type 2 allergen protein and its preparation method and application
US-11319353-B2
View DetailsRecombinant Dermatophagoides farinae type 2 allergen protein and its preparation method and application
US-11236137-B2
View DetailsSite-specific polyethylene glycolylated (pegylated) asparaginase, preparation method therefor and use thereof
US-11103565-B2
View DetailsRecombinant Dermatophagoides farinae type 1 allergen protein and its preparation method and application
US-10975128-B2
View DetailsBispecific antibody binding to human CD26 and human CD3, production method therefor and use thereof
US-10752686-B2
View Details
Variant recombinant dermatophagoides pteronyssinus type 1 allergen protein and its preparation method and application
US-11359191-B2
View DetailsRecombinant Dermatophagoides pteronyssinus type 2 allergen protein and its preparation method and application
US-11319353-B2
View DetailsRecombinant Dermatophagoides farinae type 2 allergen protein and its preparation method and application
US-11236137-B2
View DetailsSite-specific polyethylene glycolylated (pegylated) asparaginase, preparation method therefor and use thereof
US-11103565-B2
View DetailsRecombinant Dermatophagoides farinae type 1 allergen protein and its preparation method and application
US-10975128-B2
View DetailsBispecific antibody binding to human CD26 and human CD3, production method therefor and use thereof
US-10752686-B2
View DetailsProducts
Drug safety and pharmacovigilance certification program
Multi-course professional certification covering drug safety, signal detection and management, risk management planning, urgent safety procedures, pharmacoepidemiology, and clinical trial safety reporting; issues digital badge and verifiable certificate on completion.
Introduction to drug safety and pharmacovigilance
Self-paced course covering fundamentals of drug safety including pre- and post-marketing safety activities, safety databases and regulatory reporting in EU and USA.
Pharmacoepidemiology professional certification
Program comprising multiple courses on pharmacoepidemiology, signal detection, risk management and PK/PD for clinical development and post-marketing surveillance.
Pharmacokinetics and pharmacodynamics program
Program focused on PK/PD concepts, study design, sampling, analysis and bioequivalence testing, typically delivered as a two-course structure.
Biostatistics course
Course covering study design, statistical inference, hypothesis testing, sample size and power, and analyses for various outcome types used in medical research.
Adverse event reporting and terminology course
Course focused on adverse event collection, SAE reporting timelines, and controlled vocabularies and coding systems used in clinical development and post-marketing safety contexts.
Drug safety and pharmacovigilance certification program
Multi-course professional certification covering drug safety, signal detection and management, risk management planning, urgent safety procedures, pharmacoepidemiology, and clinical trial safety reporting; issues digital badge and verifiable certificate on completion.
Introduction to drug safety and pharmacovigilance
Self-paced course covering fundamentals of drug safety including pre- and post-marketing safety activities, safety databases and regulatory reporting in EU and USA.
Pharmacoepidemiology professional certification
Program comprising multiple courses on pharmacoepidemiology, signal detection, risk management and PK/PD for clinical development and post-marketing surveillance.
Pharmacokinetics and pharmacodynamics program
Program focused on PK/PD concepts, study design, sampling, analysis and bioequivalence testing, typically delivered as a two-course structure.
Biostatistics course
Course covering study design, statistical inference, hypothesis testing, sample size and power, and analyses for various outcome types used in medical research.
Adverse event reporting and terminology course
Course focused on adverse event collection, SAE reporting timelines, and controlled vocabularies and coding systems used in clinical development and post-marketing safety contexts.
Services
Design and delivery of self-paced, multimedia eLearning modules for regulatory, clinical, and manufacturing topics with immediate enrollment provisioning and a defined access period (commonly 12 months).
Subject-matter expert–led training delivered virtually or on-site to complement eLearning or as standalone sessions; supports curriculum customization for organizational needs.
Integration of eLearning with instructor-led components to create hybrid curricula that use pre-work to increase the effectiveness of live sessions and improve compliance outcomes.
Group enrollment and account management services including training manager portal access, bulk licensing credits, site-license delivery models, exportable training records, and procurement support (POs/invoices).
Administration of online assessments with configurable retry policies; automated issuance of verifiable encrypted PDF certificates (watermark, unique validation code, QR barcode) and digital badges; online credential verification tools.
Provision of a searchable online catalog with CSV/PDF export options and availability of free trial/abridged courses for evaluation prior to purchase.
Design and delivery of self-paced, multimedia eLearning modules for regulatory, clinical, and manufacturing topics with immediate enrollment provisioning and a defined access period (commonly 12 months).
Subject-matter expert–led training delivered virtually or on-site to complement eLearning or as standalone sessions; supports curriculum customization for organizational needs.
Integration of eLearning with instructor-led components to create hybrid curricula that use pre-work to increase the effectiveness of live sessions and improve compliance outcomes.
Group enrollment and account management services including training manager portal access, bulk licensing credits, site-license delivery models, exportable training records, and procurement support (POs/invoices).
Administration of online assessments with configurable retry policies; automated issuance of verifiable encrypted PDF certificates (watermark, unique validation code, QR barcode) and digital badges; online credential verification tools.
Provision of a searchable online catalog with CSV/PDF export options and availability of free trial/abridged courses for evaluation prior to purchase.
Expertise Areas
- Regulatory compliance training (GxP, 21 CFR, ISO and electronic records)
- Clinical trial conduct and pharmacovigilance education (GCP, SAE/AE reporting)
- cGMP and manufacturing quality systems training
- Computer system validation and software assurance (CSV/CSA)
Key Technologies
- Hosted learning management systems (LMS)
- SCORM and AICC eLearning packaging
- Asynchronous self-paced eLearning platforms
- Automated enrollment provisioning and credential email delivery