Praxis Medica

Helping to Bring Safe, Effective and Innovative Medical Products to Market Since 2000 Praxis Medica works with Pharmaceutical, Biologics, Medical Device and Nutraceutical companies. We provide Regulatory Affairs, Quality Assurance and Management consulting services, as well as Product Development and Commercialization Strategy assistance. Our firm specializes in Product Development and Commercialization, from the seed of an idea to the final product. We bring extensive experience and professionalism to every client and customize our support to the needs and concerns of your company. REGULATORY AFFAIRS * Strategy Development * Meetings with Global Regulatory Agencies * Global Submissions - MAA, CTA, NDS * Pre-IND, IND, ANDA, NDA, BLA, 505(b)(2), ODD, FT * 510(k), IDE, PMA, Tech File, Dossier, IFU, CER QUALITY ASSURANCE * GDP, GRP, GLP, GMP, GCP, GCLP * Master Service Agreements, Quality Agreements * Audits of Suppliers, CROs, CMOs, CDMOs, Clinical Sites * Gap Analysis, Remediation, 483, Warning Letters * Quality Systems and SOP Development and Review CHEMISTRY, MANUFACTURING & CONTROLS (CMC) * Person-in-Plant; Oversight of Contract Services * Formulation and Process Development * Analytical Method Development and Validation * In-Process and Final Product Testing; Stability Programs NONCLINICAL DEVELOPMENT * Person-in-Facility; Oversight of Contract Services * Planning of Pharmacology and Toxicology Studies * Protocol Development and Review * Final Report Audit and Review CLINICAL DEVELOPMENT * Briefing Package Development and Review * IRB/EC Applications * Protocol and Investigator's Brochure Development and Review GLOBAL SERVICES * Global Submissions * US, Canada, EMEA, LatAm, AsiaPac, Notified Bodies * Serve as US Agent for DMF, Pre-INDs, INDs, ANDAs, NDAs, BLAs * Represent Clients In Front of FDA * Regulatory Life Cycle Management