SERVICES​
With about 25 years of experience in the BioPharma industry, working on a multitude of projects from proteins, biopolymers, drug delivery, vaccines, phage, and cell therapies, we have  gained the understanding and experience as to what it takes to bring your process from R&D through the various stages of clinical manufacture.  We bring to the table the  ability to quickly learn about YOUR projeces and apply an "out of the box" thinking approach to technical situations.  
  1. CMO Management
    We lead you through the selection process for finding a suitable contract manufacturer for YOUR process. As a liaison between you and the CMO, we represent you in all day-to-day operations, including meetings, on-site visits, monitoring and guiding activities.
  2. cGMP Document Review
    Review of specifications, SOPs, batch records, deviations and OOS documentation, etc.
  3. "SME" for Downstream Processing
    Subject Matter Expert for downstream processing needs from filtration, membrane processes and chromatography to liposome and encapsulation technology
  4. Equipment Validation Support
    Guidance on IQ, OQ, and PQ activities, providing support to develop the validation strategy, review of documentation such as protocols as well as executed reports.
  5. Project Management
    Project planning, timeline creation, progress monitoring and communication between the various team players.
  6. Process Characterization and Validation
    Process reviews and FEMA risk assessments in preparation for process characterizaiton, process scale-down, review of third-party process characterization protocols and reports, review of process validation plan, protocols and reports.
  7. QA and Regulatory Support
    In support of your regulatory submissions, we compose and review CMC sections for IND and DSUR submissions as well as CTA. Technical representative during CMO and vendor audits.
  8. Technical Writing
    We provide additional technical writing services for your project such as procedures, reports, risk assessments, campaign summaries, etc.