Services

“WE ADAPT TO OUR CLIENT’S NEEDS”

The AMAR team works closely with the client throughout the program’s life cycle to exceed expectations and maintain quality services.

AMAR has two separate and operational Business Divisions – Biomedical Division and Architecture and Engineering Division. Collectively as the AMAR team, we provide quality services and adapt to our client’s needs.

 

LIFE SCIENCES

  • Data Safety and Monitoring Plan (DSMP) Review and Analysis
  • Research Program Management and Support
  • Pharmaceutical and Biotechnology Market Research for Product Development
  • Pharmaceutical and Biotechnology Product Development
  • Regulatory Affairs
  • Management Consulting and Support
  • Scientific Advisory Board
  • Systems Biology
  • Information Technology
  • Bioinformatics
  • Pre-Clinical and Clinical Research
  • Specialized areas 
    - Product Development and Research Support Services- DSMB Services- Data Management and Statistics- Medical /Technical Writing

    – Submission and Management of IND/IDE/PMA/NDA/MF

    – Review of Background Information

    – Pre-IND Meeting Preparation,

    – Regulatory Strategy Development

    – Regulatory Submissions (IND, 510k, IDE, PMA, MF, NDA, etc)

    – Audits – GLP, GCP, GMP, IBs – Creation and Review, Annual Reports (IND, MF, & IDE)

    – Regulatory Affairs Tracking and Reporting

    – Protocol Development and Management

    – Site/Investigator interactions (training, investigator’s meetings, etc)

    – Clinical Monitoring

    – SAE Processing

    – DSMB Services

    – Data Management and Statistics

    – Medical Writing

    – Submission and Management of IND/IDE/PMA/NDA/MF

    – IBs – Creation and Review

    – Annual Reports (IND, MF, & IDE) Preparation and Service

    – FDA Meetings, Teleconferences, Correspondence

    – Complete IT support for Regulatory Affairs

 

ARCHITECTURE & ENGINEERING

  • Consultation and support in Architectural/Engineering Design
    - Architectural- Mechanical- Electrical- Plumbing

    – Structural

    – Civil

    – Fire Protection

    – Environmental

    – Energy Conservation

    – CADD Documentation

    – Construction Quality Management

    – Construction Administration

    – Cost Estimating

    – Record Drawings

  • Construction Support
    - Construction Quality Management- Construction Administration- Cost Estimating
  • Special Studies
    - Americans with Disabilities Act Compliance- Building Systems Evaluations- Building Systems Renovations- Feasibility Studies

    – Historic Properties Renovations

    – Building Equipment Replacement

    – Equipment Reserve Funds Analysis