At Altabrisa Group, we specialize in guiding pharmaceutical, biotech, and medical device companies through the complexities of FDA compliance. Whether you’re preparing for a pre-approval inspection, submitting regulatory filings, or ensuring ongoing GMP compliance, our FDA readiness services help you mitigate risk, avoid costly delays, and ensure a successful regulatory outcome.
Our team of seasoned subject matter experts, each with over 20 years of experience, provide tailored solutions for organizations of all sizes. At the core of our services is our proprietary AdaptiStrat® System, a cutting-edge approach designed to deliver lasting results and drive quality. By combining our consultants’ wealth of expertise with this innovative system, we are uniquely positioned to help clients achieve their goals and create a solid foundation for compliance and regulatory success.
Comprehensive FDA-style audits
Mock inspections (PAI, surveillance, for-cause)
Detailed gap analyses against FDA regulations (21 CFR Parts 210/211, 820, etc.)
Risk prioritization and remediation plans
Comprehensive FDA-style audits
Mock inspections (PAI, surveillance, for-cause)
Detailed gap analyses against FDA regulations (21 CFR Parts 210/211, 820, etc.)
Risk prioritization and remediation plans
Comprehensive FDA-style audits
Mock inspections (PAI, surveillance, for-cause)
Detailed gap analyses against FDA regulations (21 CFR Parts 210/211, 820, etc.)
Risk prioritization and remediation plans
Comprehensive FDA-style audits
Mock inspections (PAI, surveillance, for-cause)
Detailed gap analyses against FDA regulations (21 CFR Parts 210/211, 820, etc.)
Risk prioritization and remediation plans
We combine technical depth with real-world regulatory experience to ensure you’re inspection-ready—whether for GMP, GLP, GCP, or medical device compliance. Our team includes former FDA auditors and seasoned industry professionals who understand what regulators expect and how to deliver it.
Avoid costly delays in product approval
Reduce risk of 483s and Warning Letters
Improve operational transparency and compliance culture
Enhance trust with regulators, partners, and patients
