Precision Consultants
Precision Consultants, Inc. is an FDA consulting firm that combines the science of drug development with regulatory science to give companies a competitive edge. They offer interpretation of FDA regulations, work closely with the USFDA, and provide expertise in regulatory, compliance, and quality assurance related to cGMPs, cGCPs, and QSR. Their team of former FDA officials helps fast track development and commercialization, leveraging initiatives like FDA's QbD pilot program, Critical Path, PAT, QbR, and Risk Management. They serve the drug, biologic, and medical device industries with a focus on FDA approval, regulatory strategy, compliance, and quality assurance.
Industries
Nr. of Employees
small (1-50)
Precision Consultants
San Diego and Coronado, California 92118
Products
Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics (book)
A comprehensive handbook addressing compliance, quality systems, method and process validation, change management, internal auditing and regulatory strategic planning for FDA-regulated products.
Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics (book)
A comprehensive handbook addressing compliance, quality systems, method and process validation, change management, internal auditing and regulatory strategic planning for FDA-regulated products.
Services
Strategic planning for regulatory filings and hands-on preparation of INDs, NDAs, ANDAs, BLAs, PMAs and 510(k)s, including guidance on small business fee qualification.
Mock inspections, remediation planning and inspection-readiness training to prepare organizations for regulatory agency inspections.
Gap analyses, corrective action plans and quality system upgrades to align with current regulatory expectations.
Management and technical support for scale-up, process capability control and site transfers to enable commercial manufacturing.
Risk mapping, crisis response planning and regulatory remediation strategies for operational and compliance failures.
Design of experiments, sample size calculations, statistical analysis plans and regulatory-ready statistical reporting for clinical and validation studies.
Strategic planning for regulatory filings and hands-on preparation of INDs, NDAs, ANDAs, BLAs, PMAs and 510(k)s, including guidance on small business fee qualification.
Mock inspections, remediation planning and inspection-readiness training to prepare organizations for regulatory agency inspections.
Gap analyses, corrective action plans and quality system upgrades to align with current regulatory expectations.
Management and technical support for scale-up, process capability control and site transfers to enable commercial manufacturing.
Risk mapping, crisis response planning and regulatory remediation strategies for operational and compliance failures.
Design of experiments, sample size calculations, statistical analysis plans and regulatory-ready statistical reporting for clinical and validation studies.
Expertise Areas
- Regulatory compliance and submission strategy
- Quality systems and cGMP/cGCP/QSR compliance
- Manufacturing scale-up and technology transfer
- Clinical trial quality assurance and GCP readiness
Key Technologies
- Quality by Design (QbD)
- Process Analytical Technology (PAT)
- Question-Based Review (QbR)
- Good Manufacturing/Clinical/Laboratory Practices (cGMP/cGCP/GLP)
News & Updates
FDA Fights a Battle on Two Critical Fronts
FDA is increasing scrutiny on industry submissions and enforcement, with a focus on 510(k) challenges and aggressive enforcement policies.
The Days of Aggressive FDA Enforcement Are Back!
FDA is reinstating a hard line enforcement approach, with swift actions against noncompliance, impacting product approvals and company credibility.
FDA Passes New Legislation
The FDA Amendments Act of 2007 (FDAAA) strengthens FDA’s authority, increases post-approval trials, and improves product safety.
510(k) Presents a Challenge to Medical Device Manufacturers
FDA review of 510(k) submissions is becoming more rigorous, requiring more scientific data and compliance to ensure safety and efficacy.
The Days of Aggressive FDA Enforcement Are Back!
FDA is increasing enforcement actions, including warning letters, injunctions, fines, and license suspensions, especially during product development and approval phases.
FDA Passes New Legislation
The FDAAA of 2007 enhances FDA’s regulatory powers, impacting post-market surveillance and approval processes.
FDA Fights a Battle on Two Critical Fronts
FDA is increasing scrutiny on industry submissions and enforcement, with a focus on 510(k) challenges and aggressive enforcement policies.
The Days of Aggressive FDA Enforcement Are Back!
FDA is reinstating a hard line enforcement approach, with swift actions against noncompliance, impacting product approvals and company credibility.
FDA Passes New Legislation
The FDA Amendments Act of 2007 (FDAAA) strengthens FDA’s authority, increases post-approval trials, and improves product safety.
510(k) Presents a Challenge to Medical Device Manufacturers
FDA review of 510(k) submissions is becoming more rigorous, requiring more scientific data and compliance to ensure safety and efficacy.
The Days of Aggressive FDA Enforcement Are Back!
FDA is increasing enforcement actions, including warning letters, injunctions, fines, and license suspensions, especially during product development and approval phases.
FDA Passes New Legislation
The FDAAA of 2007 enhances FDA’s regulatory powers, impacting post-market surveillance and approval processes.