Steripharm Solutions
Consulting firm focused on implementing cGMP-compliant quality management systems and quality assurance/quality control support for sterile and non-sterile pharmaceutical manufacturers. Services include regulatory compliance support, GMP training, audits, regulatory submission review, and manufacturing/technology transfer advisory services.
Industries
Nr. of Employees
small (1-50)
Steripharm Solutions
Services
Advisory services to develop and mature cGMP-compliant quality management systems and address regulatory observations.
Support for batch record review, SOP/protocol review, investigations and CAPA, and product disposition processes.
Training programs on cGMP, documentation practices, aseptic processing, and inspection readiness; includes digital/immersive training evaluations.
Preparation and compilation support for ANDA, NDA, and DMF filings and related regulatory interactions.
Method validation, stability program design, and environmental monitoring program support to meet regulatory expectations.
Support for transferring processes to CMOs or new facilities, including process documentation and oversight.
Advisory services to develop and mature cGMP-compliant quality management systems and address regulatory observations.
Support for batch record review, SOP/protocol review, investigations and CAPA, and product disposition processes.
Training programs on cGMP, documentation practices, aseptic processing, and inspection readiness; includes digital/immersive training evaluations.
Preparation and compilation support for ANDA, NDA, and DMF filings and related regulatory interactions.
Method validation, stability program design, and environmental monitoring program support to meet regulatory expectations.
Support for transferring processes to CMOs or new facilities, including process documentation and oversight.
Expertise Areas
- Regulatory compliance and FDA inspection readiness
- cGMP quality management systems
- Quality assurance and quality control for drug manufacturing
- Sterile and non-sterile pharmaceutical manufacturing
Key Technologies
- cGMP quality management systems (QMS)
- Aseptic processing
- Sterilization process validation
- eCTD compilation and regulatory submission tools
News & Updates
Discussion of evaluation of assisted, augmented, and virtual reality devices for applications in life sciences training and manufacturing quality programs; invitation to contact for digital solutions for cGMP training and compliance.
Discussion of evaluation of assisted, augmented, and virtual reality devices for applications in life sciences training and manufacturing quality programs; invitation to contact for digital solutions for cGMP training and compliance.