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Bioforce Solutions helps our clients deliver major project initiatives in clinical trials, post-approval, regulatory affairs, quality and compliance and manufacturing. We provide high-impact consultants and project teams with the competencies and experiences to get the project done right. Our consultants have track records of successfully delivering projects for leading biotech, pharmaceutical and medical device companies. We have the expertise and recent experience in the following projects and initiatives: | |  | | | Clinical Projects Submissions (NDA, IND, BLA, and 510K) Our experts prepare and file applications for traditionally synthesized drugs, biologics and medical devices. Our expert level Bio statisticians, RA professionals, medical writers, and statistical report generators (SAS® programmers) can help you meet critical deadlines. Clinical Project Management Every clinical research project has its own set of challenges. Our clinical project managers have strong backgrounds in medical science, clinical research, site monitoring, and many different therapeutic areas. Clinical Data Management From clinical database installation to database lock, we have the consultants to get the job done right. MedDRA We lead projects to implement MedDRA coding standards and maximize the efficiency of MedDRA across all departments. | | Regulatory & Bio-Manufacturing Projects Quality and Compliance Our experienced quality systems professionals deliver a wide range of projects including compliance audits and Pre- and Post-Approval Inspection Readiness planning. We are knowledgeable in current GMP, GLP, and GCP standards. Our technical writers produce Quality Manuals and SOP's. We also provide general contributors for batch record reviewing, change control and deviation work. Regulatory Services Our experienced RA experts conduct regulatory reviews and prepare regulatory documents for submissions to the FDA. Validation Services From creation of Validation Master Plans through continuing validation projects. Our experts have competencies with CSV (21 CFR Part 11), equipment, facility and process validation. Good Manufacturing Practice We conduct GMP audits, training sessions, and approve change controls.
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Please contact us to learn more about our services and how we may be able to help you.
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