Regulatory Compliance and Quality Assurance

  • Auditing
  • Training
  • Establishing and improving systems and procedures
  • Inspection preparation
  • CAPA systems and investigations
  • Preparing to make clinical material
  • Returning to compliance after regulatory action
  • CGMPs, GLPs, and GCPs
  • Inspection preparation
  • Corrective and preventive action, and investigations
  • Quality assurance/quality systems
  • Compliance briefings for senior management
  • Successfully working with FDA, teams, and contractors
Avoids compliance problems with the U.S. Food and Drug Administration and World Regulatory Agencies

        Immel Resources LLC is well-respected, with 28 years of hands-on experience in the pharmaceutical, biotechnology, medical device and related industries in quality assurance,
        regulatory compliance, and training. We are considered quality systems experts. Company founder Barbara Immel has served as chairperson of the Annual FDA Inspections             Summit hosted by FDAnews since the conference's inception. She is also chair of the quality track subcommittee for MedCon 2010, a new medical device conference being             cosponsored by the U.S. Food and Drug Administration and by the nonprofit Xavier University. As a conference organizer, and as a former long-term compliance columnist for         BioPharm magazine, our company founder talks frequently with regulatory agency personnel and industry experts. Our advice is always current, thorough, and thoughtful.

Saves you time, and reduces your workload
If you have been assigned a project that you do not have time to do, we can help. After an initial consultation, we get to work immediately to help solve a challenge, improve a system or provide training.
Quality system experts
Company founder Barbara Immel has served as a leader of grass-roots industry groups in training, documentation, and compliance, serving on the national training committees for both PhRMA and PDA for eight years. She is the author of the Quality Assurance of Pharmaceuticals chapter for the Dekker Encyclopedia of Pharmaceutical Technology. She has published more than 50 articles on quality and compliance topics over the past 20 years in the trade journals Pharmaceutical Technology, Medical Device & Diagnostic Industry, BioProcess International, and BioPharm. She has been teaching well-respected compliance classes for more than 20 years, specializing in CAPA and investigations courses since 2000.
Speeds products to market and reduces risk
By helping companies and organizations to be in compliance, we help organizations successfully pass major regulatory inspections and introduce innovative new products to market. 
Creative, innovative solutions, and international experience
We are known for our ability to see to the heart of an issue, and to suggest creative yet practical, long-term solutions. We have successfully worked with industry employees in more than 18 countries throughout North and South America, Europe, Asia, and the Caribbean. 
   Practical information that you can immediately use
We offer practical suggestions on how to establish or improve a quality system -- not simply identify any deficiencies. For high-profile assignments, such as preparing for an FDA pre-approval inspection, improving quality systems when under consent decree, helping an organization recover from an FDA warning letter, or preparing to enter the U.S. market, we work with a network of experienced and well-respected professionals. The final decision on any proposed team member(s) is up to you.
Reduces cost, and free initial consultation
You pay only for the services or project that you need. A written estimate is always provided, and any changes are discussed and mutually agreed upon in advance. We always provide a free initial consultation on all new assignments, and with prospective clients.

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