Regulatory Affairs White Papers & Case Studies

31. How Bend Bioscience Standardized Operations And Boosted Compliance 8/8/2025

    Discover how Bend Bioscience replaced its outdated CMMS with RAM to achieve rapid compliance, boost efficiency across facilities, and cut operational costs by 25%.

32. Optimizing Upstream Process Development To Increase mAb Titers 3/28/2025

    Uncover how we were able to help a client develop an efficient upstream process for a novel monoclonal antibody (mAb), resulting in a more than 100% increase in titers.

33. A Translational Mouse Model For Non-Genetic Heterotopic Ossification 3/28/2025

    Reproducing the thermal lesion/tenotomy-induced mouse model can help overcome the challenge of unpredictable heterotopic ossification localization and enable the development of targeted interventions.

34. Scalable Production Of High-Purity Nanobodies Using Yeast Expression System 9/8/2025

    Leverage scalable K. pastoris expression systems to produce high-quality nanobodies for cutting-edge therapeutic, diagnostic, and research applications.

35. Leveraging Surface Plasmon Resonance For Characterizing Ternary Complexes 6/13/2025

    Uncover how Surface Plasmon Resonance (SPR) can be used to gain real-time, label-free insights into PROTAC binding kinetics and ternary complex formation.

36. Robust, Scalable Strategy For Monodisperse Nanosuspensions Of Poorly Soluble Drugs 5/16/2025

    By tailoring the formulation strategy, selecting the appropriate excipients, and fine-tuning process conditions, see how our team was able to improve bioavailability and in vivo exposure.

37. Organizational Assessment For A Large MedTech Company 6/5/2025

    Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

38. Streamlined Facility Design: A Success Story 4/29/2024

    Examine how one medium-sized US company's need for a new aseptic compounding and fill-finish facility was addressed with a tailored solution within a challenging time-frame.

39. Acoustic Inspection Helps Campbell River Optimize Inspection Program 9/6/2024

    In this case study, explore how incorporating the SL-RAT into their maintenance program has realized significant savings for the city of Campbell River.

40. Rapid Results In A High-Stakes Dry Eye Disease Trial 6/26/2025

    This time-sensitive Phase 3 trial in dry eye disease required precision project management leveraging strong site relationships, ophthalmology-specific expertise, and data-driven site selection.