Bestech GMP Contracting
Bestech GMP Contracting, established in 2006, specializes in providing expert consulting services to the life science industries, including pharmaceuticals, biologics, medical devices, and compounding pharmacies. Their mission is to deliver best-in-class, value-added solutions through proven quality tools and strategies, working as an extension of their clients' staff to ensure compliance and success. They serve a wide range of industries and have a strong focus on quality systems, validation, auditing, staff augmentation, training, and inspection readiness, aiming to help clients navigate complex regulatory environments and achieve operational excellence.
Industries
Nr. of Employees
small (1-50)
Bestech GMP Contracting
Services
QMS design, gap assessments, remediation plans, implementation support and performance monitoring.
Systems audits, mock GMP audits, 503B outsourcing pharmacy audits and ISO 13485 / 21 CFR Part 820 internal audit support.
Commissioning and qualification of equipment/facilities/utilities, process and cleaning validation, and computerized systems validation.
Placement of experienced engineers, scientists and pharmacists in interim and project roles across validation, quality, labs and operations.
Inspection planning, SME training and simulations, backroom document support and management of regulatory responses and communications.
Development and delivery of cGMP technical training using ADDIE, instructor-led sessions, e-learning, blended learning and setup of training systems/LMS.
QMS design, gap assessments, remediation plans, implementation support and performance monitoring.
Systems audits, mock GMP audits, 503B outsourcing pharmacy audits and ISO 13485 / 21 CFR Part 820 internal audit support.
Commissioning and qualification of equipment/facilities/utilities, process and cleaning validation, and computerized systems validation.
Placement of experienced engineers, scientists and pharmacists in interim and project roles across validation, quality, labs and operations.
Inspection planning, SME training and simulations, backroom document support and management of regulatory responses and communications.
Development and delivery of cGMP technical training using ADDIE, instructor-led sessions, e-learning, blended learning and setup of training systems/LMS.
Expertise Areas
- Quality management systems
- Regulatory compliance and inspection readiness
- Validation and qualification (equipment, facilities, utilities)
- Auditing and remediation for GMP and 503B pharmacies
Key Technologies
- Process validation
- Cleaning validation
- Commissioning and qualification (C&Q)
- Computerized system validation
News & Updates
Quality System Remediation Projects
Remediation projects for various clients including EU Annex 1 compliance, FDA Warning Letter remediation, and FDA Consent Decree remediation.
Validation Projects
Qualification and validation of equipment, facilities, utilities, and processes across multiple manufacturing sites.
Assessments and Audits
FDA Warning Letter remediation, mock FDA audits, and cGMP compliance assessments.
Staff Augmentation
Providing experienced professionals for various roles including QC Lab Leaders, Project Engineers, and Quality Directors.
Training
GMP training, SOP development, and webinar presentations.
Compounding Pharmacy Projects
FDA-style audits, quality management system assessments, and remediation plans for outsourcing pharmacies.
Quality System Remediation Projects
Remediation projects for various clients including EU Annex 1 compliance, FDA Warning Letter remediation, and FDA Consent Decree remediation.
Validation Projects
Qualification and validation of equipment, facilities, utilities, and processes across multiple manufacturing sites.
Assessments and Audits
FDA Warning Letter remediation, mock FDA audits, and cGMP compliance assessments.
Staff Augmentation
Providing experienced professionals for various roles including QC Lab Leaders, Project Engineers, and Quality Directors.
Training
GMP training, SOP development, and webinar presentations.
Compounding Pharmacy Projects
FDA-style audits, quality management system assessments, and remediation plans for outsourcing pharmacies.