GMP Technical Consulting Services
Our GMP Technical Consulting Service provides direct access to a global network of seasoned experts - including former EU and US regulatory officials - who deliver comprehensive guidance throughout your product lifecycle.
Each recommendation combines technical precision with authoritative regulatory insight.
We specialize in helping clients navigate critical challenges by offering decisive, actionable expertise for situations including: strategic decision-making requiring specialized input; unexpected operational issues demanding expert resolution; and compliance assessments against current industry benchmarks. Whether addressing compliance gaps, operational uncertainties, or strategic crossroads, our consultants bring decades of regulatory and industry experience to provide clear, confident solutions.
Quality Control Support Services
Our team of seasoned Microbiology Consultants combines decades of hands-on industry experience with a proven track record in quality and compliance for complex manufacturing environments.
We provide specialized microbiology expertise across all therapeutic modalities, with particular depth in Biologics and Advanced Therapy Medicinal Products (ATMPs) – where microbiological control is critical for product quality and patient safety.
Our comprehensive support includes:
Contamination Control Strategies – Robust systems to prevent and manage microbial risks.
Sterility Assurance Programs – End-to-end solutions for sterile product manufacturing.
Cleaning & Disinfection Validation – Science-based approaches for effective contamination control.
Microbiological Method Development & Validation – Compliant, reliable methods for product testing.
Aseptic Processing Support – Expertise in aseptic techniques and process validation.
Laboratory Investigations– Root cause analysis and corrective actions for microbiological deviations.
Staff Training & Competency Development– Customized coaching for manufacturing and QA teams.
Microbiology Laboratory Design – Optimal facility layouts for contamination control.
Biological Containment Solutions – Risk-based strategies for handling potent microorganisms.
Why Choose Us
Parenteral Specialization
Focused expertise in complex modalities (mAbs, vaccines, cell therapies, LNP)
Science-Driven Compliance
Technically-grounded strategies that preempt regulatory challenges.
Global Regulatory Mastery
Proven navigation of FDA, EMA, and 30+ international frameworks.
Therapeutic Breadth
Successful delivery across all medicinal product categories.
End-to-End Solutions
Seamless support from discovery through post-approval commercialization.
Operational Synchronization
GMP-aligned solutions integrated with your quality systems.