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Regulatory Affairs     International Services     Project Management
Design Control & Documentation     Quality Assurance     Product Development

What We Do

Our scientists and engineers work with yours to design and impliment practical systems to meet FDA, ISO, and ICH quality standards and regulatory requirements specific to your medical product line.

We develop customized, linked, easy-to-use systems for:

Design Control & Documentation
  Customized linked systems to meet the most stringent QA standards integrated with project management
Project Management
  Detailed task lists for all phases applicable to your product, integrated with document and design control
Quality Assurance
  Multi-tier systems that incorporate FDA (cGMP/GLP/GTP/BCP), ICH, and ISO requirements and guidelines. Call us for our checklist and tips on how to obtain the certification you need.

Planning & Reporting
We develop plans, write protocols, provide support, analyze data, and prepare reports for:

Regulatory Affairs
  Clinical and Design Verification study design, data analysis, report writing. Writing and support of all types of submissions to global regulatory agencies
Research manuscripts
  Review of data and writing of manuscripts for publication
Product Development
  Establish technical performance, write reports to support labeling claims
Clinical Trials
  We can handle all segments from developing a plan to analyzing the data and preparing the reports
Manufacturing/Technical Support
  Process design, verification and validation; requirement specs, oversight of line design and equipment IQ/OQ/PQ

Supplemental Services
Rounding out our end-to-end services approach, we also provide:

System Audits
  Due diligence for potential investors; independent audits to assess existing systems; pre-ISO compliance audits; written reports of findings, suggestions for improvements; personnel training
  Candidate evaluations, hiring and training of scientific staff; company-wide quality systems training