GMACPHARMA Ltd are a professional Pharma Biotech industry management consultancy and clinical services business. They will help you to accelerate the commercialisation of your clinical to late stage drug pipeline products.

  • Providing you with expertise and support in the development, manufacture and supply of your clinical and commercialisation batches, to supply the clinic and to launch on to the market first time right; including CMC dossier development and preparation towards a successful NDA application, clinical and commercialisation program management and PAI preparation for FDA site approval.
  • Preparing your company, leadership and cross functional teams for Increased operational intensity and complexity such as preparation for PAI FDA / EU / MHRA activity, new drug product approval inspections and product launch and supply chain management.
  • Preparing your teams / company for the transition from R&D organisation to increasingly R&D/Commercial hybrid organisation – to support future ongoing pipeline commercialisations.
  • Selection of optimal CDMO partners to complement growth development and commercialisation plans
  • Supporting your company to access funding requirements to accelerate your growth plans through articulation of growth strategy and key funding milestones, budgets and to identify collaboration needs to complement organisational strengths and weaknesses¬†
  • Support to articulate larger scale investment needs; both internally, from corporate leadership and externally, from investment syndicates.
  • Preparing your company for a strategic sale or IPO – in support of a major milestone and increasing the chances of a smooth transition to the new entity.
  • Identifying Leadership development in partnership with Merlin Global Consultancy needs within the organisation that will accelerate growth and development of the company
  • Sustainable Elevation of the operational standard of GMP for greater first time success and streamlined quality product cycle times
  • In our experience, preparing well for transformational situations described above, only increases the chances of first time regulatory, funding, acquisition or merger success, to maximise value from the opportunity.
  • We have guided companies through many of these growth events, confidentially bringing valuable learnings from each situation to the next project.
  • GMACPHARMA have a unique foot in both front line specialised academic research and leading edge specialist industry implementation of drug delivery system solutions, connecting the dots between R&D and Commercial execution.