BioScientia Consulting
BioScientia Consulting, founded in 2015 and based in Boston, provides expert consulting services to (bio)pharmaceutical clients nationwide. They specialize in Quality and Compliance consulting, offering strategic expertise across all areas of the GxP (bio)pharmaceutical industry. Their mission is to support the success of their clients by delivering exemplary results through experienced consultants with over 20 years of industry experience. The company is committed to continuous improvement in quality compliance and offers a range of services including Quality Management System development, auditing, FDA PAI preparation, health authority audit support, project management, quality agreements, GxP training, technical writing, and gap assessments.
Industries
Nr. of Employees
small (1-50)
BioScientia Consulting
East Walpole, Massachusetts, United States, North America
Services
Development and ongoing management of QMS elements including policies, document control, CAPA, and change control for GxP-regulated organizations.
Planning and execution of internal and supplier/vendor audits, reporting, and follow-up to address identified nonconformities.
Readiness support for regulatory inspections including mock inspections, documentation review, and on-site inspection support.
Project management services for quality, compliance, and remediation projects, including cross-functional coordination and timeline management.
Drafting and negotiating quality agreements that define responsibilities and quality expectations between partners and vendors.
Development and delivery of tailored GxP training programs to meet organizational needs and regulatory requirements.
Development and ongoing management of QMS elements including policies, document control, CAPA, and change control for GxP-regulated organizations.
Planning and execution of internal and supplier/vendor audits, reporting, and follow-up to address identified nonconformities.
Readiness support for regulatory inspections including mock inspections, documentation review, and on-site inspection support.
Project management services for quality, compliance, and remediation projects, including cross-functional coordination and timeline management.
Drafting and negotiating quality agreements that define responsibilities and quality expectations between partners and vendors.
Development and delivery of tailored GxP training programs to meet organizational needs and regulatory requirements.
Expertise Areas
- Quality management systems (QMS)
- Regulatory compliance and inspection readiness
- GxP training and education
- Audit execution and remediation
Key Technologies
- GxP frameworks (cGMP/GLP/GCP) and compliance methodologies
- Quality management systems (QMS) implementation
- Audit and inspection methodologies
- SOP development and document control