Rammell Consulting Limited

Organisational Effectiveness through Records and Information Management
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We are the only UK-based specialist, independent records management consultancy for the biotech/pharmaceutical industry. The Managing Director and Principal Consultant, Eldin Rammell, has over 17 years experience in the pharmaceutical industry as an information scientist and records manager prior to establishing the business. His experience includes:

 

  • Implementation of corporate imaging and workflow solutions for case report form management
  • Implementation of an electronic trial master file system
  • Implementation of an electronic document management system using Opentext Livelink for business records
  • Leader of a post-acquisition business integration team to streamline records-related processes and systems
  • Participation in numerous change management initiatives
  • Development of local, departmental and global records retention schedules and fileplans
  • Team leadership and development up to Associate Director level within a multinational pharmaceutical company
  • Project management, including financial responsibility for budgets in excess of $1M
We have an in-depth knowledge of the legal and regulatory environment that pharmaceutical and biotechnology companies operate within, particularly with respect to the interpretation and implementation of Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP). We have 21CRF11 experience and can advise on compliance issues in this area. Our client list includes AstraZeneca, Novartis, Pfizer, Roche, amongst others.

Our “retained records manager” service is of particular value to the pharmaceutical sector. For a very reasonable annual fee, we are effectively part of your records management team, to call upon as and when you wish. You may want advice on preparing for an inspection or audit-related issues. Or perhaps you want a second opinion on a new policy you are developing or some technology you are considering. This can all be included as part of a consultancy service but allowing you to budget for it as part of your normal budgeting cycle.

We also offer a compliance audit service, specifically focusing on information and records management. As several large corporations have found to their cost, it is not sufficient to issue a records retention schedule or an email-use policy if they are not effective and operational. We can conduct an audit of your records policies, procedures and practices to protect you in the event of inspection or litigation. In a worst-case scenario, it could save your company millions….. money well spent!

We have also recently completed a project for a biotechnology company, assisting them with due diligence activities. Whether due diligence is for a funding round or for a potential acquisition or licensing deal, Rammell Consulting can assist with the organization, indexing and retrieval of documentation and data that may be requested by various third parties. Interacting with internal and external due diligence teams as well as other third parties involved (e.g. IP lawyers, investment banks, ‘clean teams’), Rammell Consulting can relieve some of the pressure on your staff, allowing them to concentrate on the “science” and on their routine day-to-day activities. But why wait until you are in a due diligence situation? We can help you organize and index your records now to facilitate efficient access and retrieval for any future due diligence needs.