Technical Writing

Source life science consulting experienced technical writers include scientists and industry professionals who routinely draft and compile persuasive regulatory and scientific analyses. Our depth of experience in the preparation of such material positions us to address your communication needs in a variety of ways.

Our consultants are particularly skilled in assessing and enhancing quality assurance and controls-from the way technical issues are handled to the organizational structure of quality units. Leveraging vast knowledge and experience our Consultants assists clients in:

  • Evaluating written procedures and standard operating procedures,Policy, SOP & Batch Record Review, Preparation & Optimisation
  • Helping to interpret regulations in concert with industry standards.
  • Developing laboratory quality, analytical methods, methods validations, and product component specifications.
  • Creating a program to meet current FDA expectations for cGMP Compliance.
  • Consulting self-evaluations.
  • Building sampling plans.
  • Performing trend analysis.
  • Providing corporate oversight programs and enhancement —including good governance practices; corporate quality/compliance functions and oversight practices; and independent advice to CEOs, senior managers, and board members.
  • Implementing site oversight programs, including internal audits and performance metrics.
  • Reviewing and enhancing management controls.
  • Reviewing and enhancing organizational structures —including functions, reporting relationships, responsibilities, staffing and competence; communication systems and performance (vertical and horizontal); and independence, staffing, and competence of quality units.
  • Our audiences have included, among others, FDA, medical professionals, attorneys, investors, and consumers. If you require clear and concise FDA correspondence, integrated summaries of efficacy and safety, white papers, literature articles, manuscripts or other materials, call on SOURCE LIFE SCIENCE CONSULTING LLC.