Our GMP auditing services include:
- Mock Pre-Approval Inspections (PAI) and mock FDA audits
- Mock Notified Body Inspections
- Mock Recalls
- Vendor/Supplier Audits
- MDSAP Audits
- Formal Risk Assessments & Mitigation Strategies
- Quality System & Corporate SOP Gap Analysis
Additionally, we assist with:
- Compliance Master Planning & Strategy
- Corrective Actions & Implementation Plans
- Remediation Project Planning & Execution
- Validation & Qualification
- Quality System & Corporate SOP Development
- Training Program Development
Specialized Audits:
- GCP Auditing
- GLP Auditing
- Vendor/Supplier Auditing
- Pharmacovigilance Auditing
- Data Integrity Auditing
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Access leading experts in FDA auditing and remediation services.
Join the countless Pharmaceutical, Medical Device, and Biotech Companies that rely on BioBoston Consulting to achieve and sustain GMP compliance. Trusted by leading Life Science Companies, BioBoston Consulting connects you with top GMP experts to ensure projects are executed efficiently, on schedule, and within budget.
We support all Type of Audis including your mock FDA Audits, GMP, GCP, GLP, Suppliers, internal audits and other compliance assessments.
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Partner with Former FDA Professionals
With a team of former FDA experts, we ensure that you have access to the right professionals, providing the knowledge and expertise needed to drive success.
Access Specialized Expertise in Life Sciences
BioBoston Consulting brings firsthand experience from professionals who have worked in the roles where the finer details truly matter helping you find the right GMP resources quickly and efficiently.
Leverage Our Team of Experienced Auditors
We understand your resourcing needs and provide you with the right experts, all at competitive rates. With dedicated account management at every step.
Mock FDA Inspections/Audits
FDA inspections can be challenging, with severe consequences for noncompliance, including warning letters or even shutdowns. To avoid unexpected challenges, many executives choose to conduct mock inspections to pinpoint potential issues before the real inspection.
Our mock FDA audits help identify compliance gaps, giving you the confidence to address issues in advance and ensure your operations are up to FDA standards.
GMP Auditing Services
Our quality professionals bring direct experience in Pharmaceuticals, Biotechnology, Combination Products, and Medical Device development and manufacturing. We assist you at every stage of product development, ensuring that your quality assurance needs are met.
Collaborating closely with your team, we improve processes in manufacturing, distribution, and packaging facilities. Our team leads the way in planning, executing, and analyzing audits to uncover deficiencies, make necessary improvements, and empower your team to maintain compliance for the long term.
Access Specialized Expertise in Life Sciences.
Looking for a reliable consultant or an outsourced project partner? BioBoston Consulting has a team of top industry talent to help Life Science Companies successfully execute projects from start to finish, with or without dedicated account management.
Unlock the cost efficiencies while benefiting from the expertise of the best specialists in the industry. We ensure you receive the knowledge and support needed, so you can focus on what lies ahead.
Our GMP auditing services include:
- Mock Pre-Approval Inspections (PAI) and mock FDA audits
- Mock Notified Body Inspections
- Mock Recalls
- Vendor/Supplier Audits
- MDSAP Audits
- Formal Risk Assessments & Mitigation Strategies
- Quality System & Corporate SOP Gap Analysis
Additionally, we assist with:
- Compliance Master Planning & Strategy
- Corrective Actions & Implementation Plans
- Remediation Project Planning & Execution
- Validation & Qualification
- Quality System & Corporate SOP Development
- Training Program Development
Specialized Audits:
- GCP Auditing
- GLP Auditing
- Vendor/Supplier Auditing
- Pharmacovigilance Auditing
- Data Integrity Auditing
Our Compliance Remediation Services include:
- Regulatory Observation/Warning Letter Responses & Remediation
- PAI & Inspection Readiness
- Internal Audit & Remediation Services
- Non-Conformance/Deviation Investigation Management Support
- Process Analysis & Enhancement
- Investigation, Action Plan, & Effectiveness Check
Compliance Remediation
If you’re concerned that your quality system doesn’t align with FDA expectations, our active remediation approach goes beyond consulting to solve a range of compliance challenges. We provide ongoing project management and training to ensure your quality system remains in compliance long after remediation is complete.
Our 4-Step Approach to Remediation:
- Analyze observations and select the quality investigation model best suited to uncover compliance issues.
- Launch an internal investigation with key stakeholders to assess affected processes and identify root causes of noncompliance.
- Draft a comprehensive remediation plan and secure agreement from all stakeholders.
- Implement corrective and preventive actions, with the right level of supervision and monitoring to ensure successful execution.
Third-party remediation professionals bring a fresh perspective, working diligently to analyze gaps, identify root causes, and resolve compliance issues, all while ensuring your efforts are effectively communicated to regulators.
You Deserve an Auditing Partner with a true Passion for Life Sciences
And we are that Partner.
At BioBoston Consulting, we don’t spread ourselves across multiple industries. Instead, we focus exclusively on Life Sciences, offering a deeper, more specialized pool of talent at the rates you need. With a robust team of internal resources and a vast global network, we provide access to specialists exactly where and when you need them.
We help thousands of companies, including Global Pharmaceutical, Biotech, and Medical Device Organizations, connect with the right experts through the most effective workforce model for their needs.
Let’s get started! Have a question for our team or want to set up a consultation call? Fill out the form below and a member of our team will reach out to you in the next 24 business hours.