How We Operate
Our leadership team has extensive experience and a successful track record in providing prompt solutions and recommendations. Our team has over 100 years of experience to assess and meet FDA regulatory and compliance requirements; including training, efficient auditing and complete thorough documentation.
This is what we do:
- Provide superior customer care to our clients
- Respect and value our relationships with all parties
- Deliver quick efficient site visits and written documentation
- Together, bring your company into compliance.
We provide, timely, accurate, professional and thorough results. We are committed to maximizing your efforts to bring your company into compliance and meet current, as well as, future FDA regulatory and/or ISO requirements.
Team
Hamke East Consulting is an elite team of globally-certified regulatory, clinical, and quality system professionals whose track record of delivering sensible solutions assures customer needs are met. This proven commitment and credentials ensure that each client realizes superior value.
Laura Hamke
President
Laura Hamke has over 40 years of compliance and regulatory experience in pharmaceutics, medical devices, and biotech. Starting out as an Histologist for Syntex, developer of the “birth control pill”, she rapidly moved into Quality Assurance and on to Regulatory Affairs. With changing times, Laura adapted and began working as an Independent Consultant for a major 3rd party FDA consulting house. Gaining incredible experiential momentum, Laura quickly realized her well-developed skillset and went 100% entrepreneur launching Hamke East Consulting, Inc. Over the past 18 years Laura collected a team of experts and a long list of satisfied prestigious clients.
Nate Williams
CEO
Nate Williams, has more than 20 years experience in diverse areas of third party FDA auditing. This experience continuously contributes to the business goals of medical research client companies ranging from small start-ups to large international enterprises. This ability to devise and implement intelligent strategic plans yields superior outcomes. As Business Development Director of Hamke East Consulting, an international, third-party FDA pharmaceutical, medical device auditing Corporation, he was the key liaison between the consulting teams, the client, and FDA approval.
Diana Costain
Vice President of Business Development
Diana Costain is an accomplished business development executive with a proven track record of deal-making. She brings 30 years of progressive, hands-on experience in strategic planning and execution of process development. She began her career as a securities stockbroker and subsequently became managing director of an overseas investment company. Diana reviewed and analyzed operations for companies; guiding them through restructuring, streamlining and financing, and provided management and financial control.
ISABEL ALEXANDER BANERJEE
Chemical distribution and Supply Chain Specialist; Auditor
Isabel Banerjee has demonstrated expertise in diverse product development, commercial manufacturing, chemical marketing, distribution and process, quality control, global supply chain, quality systems and supply chain management. Isabel founded an award winning, $10 million+ international chemical wholesale procurement & logistics business, Phancorp Inc., which was ISO 9002 certified. Mrs. Banerjee has participated in international trade missions, contributed articles to trade publications, lectured at academic institutions and been interviewed in multiple publications and radio programs.
Services
Our team has over 100 years of experience to assess and assist your company in obtaining FDA regulatory and compliance requirements
AUDITING
- Design Specific Audit Schedules
- Conduct Internal Audit with GAP Analysis
- Conduct External Audits of Suppliers and Sub-Contractors
- Prepare Audit Reports with Recommended Corrective Actions
- Conduct Follow-up Audits
DOCUMENTATION QSR/GMP/ISO TRAINING
- Evaluate Existing Documentation System
- Create a Basic Documentation System
- Implement a Documentation System
- Write Documents (Quality Manual, SOPs, Work Instructions)
- Conduct Training to New/Revised Documents
- Evaluate Existing Training Programs
- Design and Conduct Tailored Training Programs
PMA NDA 510(k) FILINGS
- Write NDAs/ANDAs, PMAs, PLAs/BLAs, 510(k)s
- Evaluate Existing NDAs/ANDAs, PMAs, PLAs/BLAs, 510(k)s
- Design a Plan of Action to Address Identified Deficiencies
- Establish and Implement Timelines to Meet Filing Dates
Clients
- Abbott Laboratories, North Chicago, Il
- Alpharma, Inc., Fort Lee, NJ
- Becton Dickinson Immunocytometry, San Jose, CA
- Brahms Diagnostica GmbH, Hennigsdorf, Germany
- Celtrix Pharmaceuticals, Inc., Santa Clara, CA
- Chrysalis Technologies, Inc., Richmond, CA
- COR Therapeutics, Inc., South San Francisco, CA
- DAKO Corporation, Carpenteria, CA
- Quintiles Consulting, Inc., USA
- Ortho Diagnostics Inc., Raritan, NJ
- Peptisyntha S. A., Brussels, Belgium
- Pharmaplan -Valicor, Southborough, MA
- Stryker Howmedica Osteonics, Allentown, NJ
- Syntex Laboratories, Inc., Palo Alto, CA
- SYVA, Mountain View, CA
- Ethicon, Inc, Somerville, NJ
- Inveresk, Edinburgh, Scotland, UK
CONTACT
Hamke East Consulting, Inc. will not be liable for any errors or omissions in this information nor for the availability of this information. The owner will not be liable for any losses, injuries, or damages from the display or use of this information.