BCS specializes in Validation, Quality Assurance and General Manufacturing Consulting Services for the Pharmaceutical, Biotechnology and Medical Devices industries.
Our personnel have experience working on highly-regulated environments such as consent decrees and remediation initiatives either as internal resources and/or third party reviewers. Environments in which work has to be done under time-window and budget constraints to comply with regulatory agencies.
BCS validation services include but are not limited to:
- Validation Project Management
- Project Management
- Facility and Utility Commissioning and Validation
- Validation Master Planning
- Process Equipment Validation
- Process Validation
- Computer Systems Validation
- Cleaning Validation & Cleaning Validation Strategies
- Standard Operating Procedures Preparation
- Utility and Equipment Specification Development
- Analytical Test Methods Validation
- Validation and Quality Assurance Systems Gap Analysis
- Training and Education in cGMP, GLP and 21CFR Part 11 Regulations
Regulatory & Compliance
Our quality/regulatory oriented personnel is able to fulfill your needs on the following but not limited areas:
- Vendor qualification and inspection of suppliers
- Contract Manufacturing and Laboratories Methods Validation
- Quality Assurance Systems Gap Analysis, Investigations, CAPA’s and technical writing development
- Training and education in cGMP’s, GLP’s and 21 CFR Part 11
- Third party review services
Our Quality Assurance and Regulatory Affairs professionals bring additional expertise and resources to your company.
Our staff provides Gap Analysis and Remediation for compliance with 21CFR Part11 (Electronic Records and Electronic Signatures regulation), GLP and cGMP requirements.