success stories to build on
for your pharma and biotech projects.



  • Fast-track new product development project for small-molecule injectable. Delivered ambitious method validation and stability programme. Dossier preparation and review, response to authority questions.
  • Product quality issue. Systematic root cause investigation and data analysis carried out. Formulation change proposed and implemented. Presentation to senior management and regulatory body to get buy-in for approach.  
  • Geographic expansion of legacy product. Dossier gap analysis and updates. Management of analytical CRO to carry out identification of new impurities and method update.
  • Process development for autologous cell culture. Identification of critical process parameters. Dossier update for clinical trial application.
  • Formulation development for oral dissolvable film and product transfer to CMO for manufacturing of clinical trial material. Project management. Dossier generation.


  • Drug substance: small molecules, peptides, biologics, cells
  • Drug product: injectables (solutions, emulsions, lyophilisates), solid dosage forms, oral dissolvable films
  • Container closure systems: glass vials, blow-fill-seal, pre-filled syringes, infusion bags
  • Extractables & Leachables. Related substances and elemental impurities.


  • Systematic review and gap analysis of technical information in seller's virtual data rooms. Compilation of key facts and figures.
  • Evaluation of project maturity and robustness. Risk identification and assessment. Estimation of Probability of Technical and Regulatory Success (PTRS).
  • Contributed to several successful transactions valued at more than $1.5bn.


  • Short-term assignments to step in as functional manager and team leader upon departure of previous job holder or during times of transition
  • Experience with remote management and leadership for virtual teams
  • Change management and organisational development
  • Established competence mapping and gap analysis, set up personal development plans


  • Change management project to re-invigorate innovation culture at large healthcare company
  • Set up of scouting and innovation teams. Facilitation of employee workshops to develop action plans.
  • Organisation of Innovation Challenge. Identification and evaluation of relevant start-up companies to participate.