• phone : 623-412-8515
    Fax : 623-412-8525
Services – Pharmaceutical, Biopharmaceutical and Medical Devices

We provide a full range of services to support the client’s existing operations along with their needs to expand their operation with new products, and improvements in facilities and processes.

FDA Audit Remediation Projects ( Pharmaceutical, Biopharmaceutical, Medical Devices)

We provide a full range of services for your FDA audit remediation projects

  • Preparing the response letter to FDA observations
  • Pre-Audits for preparation for the FDA inspections
  • Equipment Requalification & Process Revalidation
  • Drug Application Data Integrity Verification by FDA Certified Consultants
  • Quality System Enhancements

Validation (Pharmaceutical, Biopharmaceutical, Medical Device)

We provide consulting services for our clients to comply with latest guidelines by ICH and FDA for the following:

  • Process validation and Life Cycle System Approach
  • Quality by Design and Design Space concept adaption to legacy and new products and processes
  • Validation Master Plan
  • Utilities & Equipment Qualification
  • Cleaning Validation
  • Computer System Validation
  • Building Automation System Validation
  • Revalidation based on annual product reviews and process performance history (Life Cycle Approach)

Quality System Enhancements ( Pharmaceutical, Biopharmaceutical, Medical Device)

  • Internal Audits
  • Risk Assessment Based Quality System Development
  • Gap Analysis
  • Investigations
  • CAPA Management and Execution
  • Calibration Management
  • Annual Product Reviews

Regulatory Affairs ( Pharmaceutical, Biopharmaceutical, Medical Device)

  • IND, NDA and ANDA Filing
  • Annual Product Reports
  • GDUFA
  • eCTD
  • Self ID for Suppliers and Contract Facilities
  • 510 K Filing

Project Management Services ( Pharmaceutical, Biopharmaceutical, Medical Device)

  • Greenfield Project Report including the Budget and Marketing Development
  • Facility Design, Build-Out and Commissioning
    • Oral Solids
    • Semi-Solids
    • Sterile Products
    • Highly Potent & Beta-Lactam Products

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