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Pharma Medica Research Inc.
Latifa Yamlahi, President & CEO
966 Pantera Drive, Unit 31
Mississauga, Ontario L4W 2S1 Canada
Phone: 905-624-9115
Fax: 905-624-4433
E-mail:
Web: http://www.pharmamedica.com
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Company Overview
Science is the foundation, Pharma Medica is the source
Pharma Medica Research Inc. (PMRI) is a Contract Research Organization offering Clinical Trials Research (Phases I-IV), Bio-Analytical, Regulatory, Data Management and Statistical Services. Our clients include brand name pharmaceutical, generic pharmaceutical, and biotechnology companies worldwide.
PMRI employs full time professionals including physicians, study coordinators, nurses, and other allied health professionals with extensive expertise in a number of therapeutic areas to meet our client's need.
PMRI has conducted more than 1000 clinical trials in its GCP-compliant, modern, 160-bed clinical facility and has developed more than 165 bio-analytical assay methods in its state-of-the-art, GLP compliant bio-analytical laboratory.
PMRI is dedicated to building long-term relationships with its clients by providing quality data on time, every time and at a competitive cost through its exceptionally capable and dedicated team of scientific and business professionals.
Phase I Clinical Unit
- Three independent clinics housed within a 25,000 square foot facility
- Total capacity of 160-beds
- Clinical Protocol
- Study Design
- IRB/ERB Submission
- First-in-human
- Bioequivalence and Bioavailability
- Pharmacokinetics and Pharmacodynamics
- Dose Escalation, Safety, and Tolerability
- Drug-Drug Interaction
- Special Population
- Extensive Subject Database
Bio-Analytical Service
- Specializes in developing and validating highly sensitive bioanalytical assays
- Expertise in multiple analytes (Drug and Metabolite) assays
- Fast turn around time using state-of-the art Sciex API 4000 and 3000 LC/MS/MS Systems combined with high through put Automated SPE Sample Preparation Station
- Over 165 validated assay methods
Regulatory Affairs
- IND, ANDA/ANDS, NDA/NDS, CTA Preparation and Filing
- 510k Preparation and Filing
- FDA Electronic Submissions
- Pre and Post Approval Consultation
- SOP Development
- GMP Audit and Training
Data Management & Statistical Services
- Double Data Entry and Verification to FDA, TPD, or European Formats
- Customized Data Listings and Statistical Analysis using SAS
- Adverse Event, Medication Coding and Randomization Scheme using SAS
- Sample Size Determination
- Data Query Resolution
- Clinical, Analytical, & Statistical Reports
Phase II- IV Clinical Services
- Pre-Study/Initiation/Monitoring/Close-Out Visits (US & Canada)
- Clinical Sites Selection and Management (Canada)
- Clinical Site Monitoring & Management (US & Canada)
- Investigator Recruitment
- Query Resolution
Facilities
Corporate Headquarters and Bio-Analytical Laboratory
966 Pantera Drive, Unit 31
Mississauga, ON, Canada L4W 2S1
Phone: 905-624-9115
Fax: 905-624-4433
Phase I Clinical Unit
1410 Warden Avenue
Toronto, Ontario M1R 5A3 Canada
Phone: 416-759-4111
Fax: 416-759-2869
Clients and Customers
- Brand name pharmaceutical companies
- Generic pharmaceutical companies
- Biotechnology companies
Pharma Medica Research Inc.
Latifa Yamlahi, President & CEO
966 Pantera Drive, Unit 31
Mississauga, Ontario L4W 2S1 Canada
Phone: 905-624-9115
Fax: 905-624-4433
E-mail:
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