PROJECT CASE STUDIES
The Peritus Team has the breadth & depth of experience and expertise to support product development and regulatory affairs for therapeutic and medical devices.
For early stage development, Peritus provides a ‘one-stop-development’ team – ideal for start-ups, spin-outs, SMEs and early stage investors.
We support bio-pharmaceutical companies with development projects and on-going regulatory support requirements.
Client: Virtual Biotech Start-up
Activity:
Performed Head of CMC role for a virtual company that was developing a vaccine product at the pre-clinical stage.
Built and managed relationships with CDMO and CRO partners in US/EU performing technical studies and GMP activities.
Provided strategic support covering all project aspects to enable timely delivery of company objectives.
Value:
Peritus Regulatory consultants understand product development and provide strategic value to small biotech companies through vendor selection and engagement, project management covering all CMC, non-clinical and clinical activities, detailed technical knowledge and its application to study design and regulatory requirements at different stages of development. Peritus regulatory consultants develop and adhere to the target product profile and identify associated program risks whilst meeting the cost and time pressure requirements associated with biotech start ups.
Client: Mid-sized Biotech with a Late-stage Product Ready for Licensing:
Activity:
Developed marketing application approaches for US and EU in parallel for a monoclonal antibody. We wrote module 1-5 documents, building in historical Agency feedback and different regional requirements, working closely with subject matter experts both internal and external to identify, understand and solve issues in studies and source documentation, ensuring an efficient submission document review process by writing high quality first drafts and including the required level of detail in each module section. All underpinned with excellent project management to engage all contributors and stakeholders and ensure timelines are realistically set and then met.
Subsequently provided support during marketing application review process by identifying and mitigating Agency questions before they arose, coordinating and providing input into response to Agency questions, and planning post-approval strategies to implement changes.
Value:
Peritus Regulatory Consultants have collective expertise across a broad range of biotech products and use this knowledge to write high quality regulatory marketing applications. Peritus Regulatory consultants provide carefully written concise responses to Agency questions during marketing application review in order to defend the clients position, minimise the number of post-approval commitments and obtain the marketing approval as quickly as possible.
Client: European Biotech Company - Analytical Support
Activity:
Constructed detailed analytical summary reports for product impurities characterization and forced degradation studies relating to a monoclonal antibody product in late-stage development. Summary reports constructed from several separate CRO reports; output was used directly in a commercial license application.
Value:
Peritus Regulatory consultants have the experience and know how required to construct value-adding CMC reports by interpreting complex data sets, presenting results and making conclusions with context, in a submission ready format.