Preclinical pharmacology/toxicology programs to support Phase I clinical trials Expedited regulatory mechanisms Regulatory strategies to gain competitive advantage Rapid and uninterrupted clinical development Human subjects protection Strategies for combination products Leveraging discovery research Meeting with the FDA

 

 

Pharmacology Toxicology
            Preclinical Development planning
                        Small molecule
                        Biotechnology derived
                        Cellular therapy
                        Gene therapy
                        Blood Products
            Study design
                        Evaluation
                        Design
            Compliance with FDA, ICH and ISO guidances

Regulatory Strategy
            Fast Track Applications
            Expedited Review
            Accelerated Approval

Due Diligence
            Preclinical evaluation
            GLP, GMP evaluation
            Regulatory compliance

Product Development
            Indication
            Preclinical            

Clinical Trial Development
            Compliance with FDA Guidance

Combination Products
            Request for Designation
            Regulatory strategy development

Tissue Engineered Pharmaceuticals

Preparation of regulatory documents and applications
            Review and Comment
            Content development

Institutional Review Board
            Development of Informed Consent Documents
            Investigators Brochure
            Biological Pharmaceuticals

Facility inspections
            Preparation
            SOP development
            Facility Review

Manufacturing            

Regulatory meeting preparation
            Pre-IND, IND, BLA, NDA

Regulatory Device
            Biological
            IDE preparation

Process Validation
            GMP
            Process scale
            Release Criteria

Product Labeling
            Marketing Review

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