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
Company Details
- Employees
- 5
- Founded
- -
- Address
- 6060 Poplar Ave, Memphis,tennessee 38119,united States
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- praxismedica.us
- Keywords
- Regulatory Affairs, Quality Assurance, Chemistry, Manufacturing and Controls (CMC), Non-Clinical Development, Clinical Development, R&D Support, Metrology, Project Management, Global Services, Pharmaceuticals, Biologics, Medical Devices, Nutraceuticals, Consuting.
- HQ
- Memphis, Tennessee
Praxis Medica Questions
Praxis Medica's website is praxismedica.us
Praxis Medica's LinkedIn profile is https://www.linkedin.com/company/praxismedica
Praxis Medica has
5 employees.
View email and phone details for 5
employees at Praxis Medica.
Praxis Medica's industry is
Business Consulting and Services
Praxis Medica's top competitors are
Syngenta,
Medica Praxis,
Axonlab Nederland,
Praxis Medical Devices,
El Pharma – Phoenix Group Representation Services,
Paypoint Romania.
Praxis Medica's categories are Business Consulting and Services
Praxis Medica's founding year is 2000
