Regulatory and Quality Consulting Services
Eurofins BioPharma Product Testing network of laboratories provides expert consulting services to support customers’ development, manufacturing, regulatory and legal needs.
Our technical, quality and regulatory experts have extensive experience in the biotechnology and pharmaceutical drug product industries with specific consulting services expertise, including:
Regulatory Consulting Services
- Raw material specifications preparation, review, and editing
- Specifications development/evaluation
- Subject Matter Expert (SME) attendance at regulatory review meetings
- Trouble shooting QC, drug product stability, and manufacturing problems
- Expert Witness
- GMP-site inspections
- GMP training, including in-house and off-site GMP staff training
- SOP development, review and implementation
- Pre-approval Inspection (PAI) preparation, mock audits, and support
- Assistance with Health Canada, FDA and EMA audits from preparation, pre-regulatory inspection audits, attendance at audit, from start to close-out
- Performing audits of third-party vendors, contractors, API sites, etc.
- Manufacturing facility assessment and on-site product inspection
- Remediation and response to regulatory-driven findings (483s, warning letters, consent decrees)
- Assisting in CMO evaluation, selection and qualification
- Site visits (e.g. vendor qualifications and audits)
- Third-party audits/self-inspections/regulatory audits for drugs, natural health products, APIs, and cosmetic manufacturers/packagers/labelers/testers
- Attending internal meetings (in person or by phone)
- Attending external meetings such as regulatory review meetings (in person or by phone)
- Providing depositions and testimony in legal cases
- Preparation of technical agreements
- Medical marijuana site inspections
- Qualified Persons (QP) to certify the release of a drug product
Quality Control and Quality Assurance Services
- Development and implementation of GMP-compliant quality systems for importers, wholesalers, and third-party logistics of finished products and APIs
- Preparation of Finished Product Specifications
- GMP-document review
- Product-release assistance
- Establish stability program as per ICH requirements
- Deviation, Corrective Action Preventative Action (CAPA) assistance
- Handling of quality complaints and product recalls
- Temperature excursion studies, transportation studies, and validations
- Annual product review
- GMP compliance services to US companies who want to market drugs, natural health products, medical devices and APIs in Canada
- Third-party importation QC and warehouse support
