Policies & Procedure Drafting & Review

Effective policies and procedures are the foundation of any pharmaceutical company. Policies address the “why” where as procedures answer the “who, what, when, and where”. The “how” is typically specified in training materials, user guides, checklists, and so forth. When well written, policies and procedures provide consistency of outcomes, clarity to employees, cost savings, and protection of loss of institutional knowledge. The level of detail should be proportional to the level of risk - preventing variance where business, legal, or regulatory risk exists and permitting latitude where risk is low.

CIS’s approach to policy/procedural development takes the baseline of industry practice, considers the particulars of the client’s company, and develops methods that fit the client’s business needs while improving efficiency, rationality, and adaptability of the operation. Depending on the client’s needs, our assessments evaluate:

  • Processes, systems and internal controls
  • Shortfalls relating to regulatory requirements
  • Potential improvements, streamlining processes
  • Dissemination of information
  • Documentation of how processes are communicated

When an opportunity for improvement is identified, CIS brings together the key stakeholders for the particular process, facilitating negotiations and achieving consensus on the process. CIS reviews and produces a final product that most effectively serves our client’s needs.

Our wealth of experience and knowledge allows us to serve our clients in developing effective policies and procedures in all aspects of the pharmaceutical industry from Manufacturing through Marketing.