Remote GxP Consultancy
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COVID-19 Support Services for the Pharmaceutical Industry
Our first priority is protecting the health and safety of our colleagues and clients while still providing valuable public health services. Our team is here to help you and the health care industry through these uncertain and fast-moving times.
We provide a wide range of virtual and remote pharmaceutical auditing, consulting and training services aimed to help companies to continue operating under the COVID-19 restrictions.
Full-Service Contract Research Organization
NSF International now offers the services of a full contract research organization (CRO), and has significant expertise conducting biomedical research. Our team’s combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. These services include:
- Adaptive study designs
- Antibody product for HIV treatment being used for COVID-19 patients
- Biostatstics
- Clinical operations
- Data management
- Data monitoring committees, medical writing and consulting
- Investigational New Drug Applications (INDs)
- Medical safety and pharmacovigilance
- Pharmacovigilance
- Project management (Phase I-IV, BE/BA, PK/PD)
- Project/trial management
- Regulatory affairs (FDA applications and meetings, applications to international health authorities and GxP compliance audits)
- Statistical analysis
We can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application.
Remote Desktop and Virtual GMP Audits
We have developed and trialed a four-step approach that helps unlock supply chains and meet cGMP needs in technology transfer, clinical trial supply and routine operation. This approach allows for a risk-based method that will help to provide interim or conditional approval of facilities and quality systems -- especially during periods of uncertainty and governmental restrictions.
Consulting Services
Our consulting services relevant during these difficult times include:
- Remote authoring/review of GxP policies and SOPs
- Remote support of PQS
- Mentoring
- Cleanroom and aseptic technique procedures and training
- Commercial manufacturing of hand sanitizers
- Compassion Use Approvals (CUAs)
- Emergency Use Authorizations (EUAs)
- Investigational Device Exemptions (IDEs)
- Regulatory requirements for hand sanitizers
- Vaccine manufacturing and testing
eLearning and Virtual Training
When in-person learning or training is not possible, we offer options to keep staff up to date.
eLearning: Our full range of eLearning courses for both the pharmaceutical and medical device industries can be customized to meet your organizational needs. Now is the perfect time to educate your entire workforce, groups or individual employees in topics relevant to their job role.
Virtual training: With many more of us working together remotely, we are now offering our training programs virtually with experts to guide you in an interactive and engaging virtual classroom. Our instructor-led training can be customized to your organizational requirements – we are already working with our clients to meet their exact needs.
Do not postpone the development of your staff; maximize their contribution to the business and improve your competitive edge. Our virtual training courses complement our 2020 public training schedule.