(NDA, IND, BLA, and 510K)
Bioforce Solutions' 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
We provide expertise from clinical database installation to database lock. If you have hundreds or millions of CRF pages, we have the resources to get the job done right.
We lead projects to implement MedDRA coding standards and maximize the efficiency of MedDRA across all departments. We supply individual coders for data management, drug safety and centralized coding groups.
Good Manufacturing Practice
We conduct GMP audits, training sessions, and approve change controls.
Quality and Compliance
Our experienced quality (QA/QC) professionals deliver a wide range of projects including compliance audits and Pre- and Post-Approval Inspection Readiness planning. We have experienced resources in 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.
Our experienced RA experts conduct regulatory reviews and prepare regulatory documents for submissions to regulatory agencies.
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.