MD PHARMACON is an experienced, consulting group focused on the global pharmaceutical industry covering services for an extensive portfolio of medicinal products (new chemical entities, generic/hybrid/WEU, novel formulations/administrations, biosimilars, paediatric formulations, OTC, herbals).
Business and product development
an extensive range of services including: Pharmaceutical and formulation development, Applied analytical services, Dossier medical writing (Modules 2-5), Biowaiver documentation reports, Review and evaluation of administrative data and/or supporting scientific documentation before dossier acquisition or submission
Global Regulatory Affairs (main area-EU)
a wide range of quality services in the area of Regulatory Affairs to support the successful authorisation of medicinal products, including: strategic advice and guidance on all Regulatory procedures, Common Technical Document (CTD) dossier preparation, Dossier upgrade/CTD conversion, Supervision and support throughout the process
in collaboration with highly-skilled specialised CROs wherever needed,we can offer a wide range of services including:
• Full regulatory consulting support
• Protocol design
• Access to Clinical unit and Bio-analytical site
• Pharmacokinetic and statistical analysis
• Final report eport writing
high level scientific advice on the appropriate tests and studies that are required in the development of a medicine, applied in a wide range of products in order to facilitate the development and availability of high-quality, effective and acceptably safe medicines.
Training programmes and Workshops
Whether you are new to the pharmaceutical business, or just seek the training solutions that can take you to the next level, MD PHARMACON can also provide your company customised training programmes tailored to your specific needs and objectives in order to meet the demands of the constantly evolving and even changing pharmaceutical legislation and regulatory/scientific framework.