Regardless of whether we are dealing with the complex and challenging technology of a soft mist inhaler (SMI) or the development of dry powder inhalers (DPI) – our experts will support you on the path to market launch. The comprehensive expertise of our consultants regarding devices, technology and international regulations forms the basis of a secure development process. You will receive support in the area of design for commercial production as well as the associated development documentation, among others.
Validation & Quality Systems
The significance of the “Quality by Design” approach for reliable process control is emphasized in Annex 15 of the EU Guide to Good Manufacturing Practice. Our services in the area of Validation & Quality Systems are clearly orientated around this concept. We offer support in developing a qualification/validation strategy, including creating the corresponding documents. You will also receive reliable advice regarding product and process validation. Risk management is carried out on the basis of the principles of ICH.
The consultancy services of our consulting team for pharmaceutical product development and medical devices are based on our extensive experience in the areas of formulation, development, production and packaging – and for a variety of dosage forms. Additional support is provided by Harro Höfliger’s Pharma Services when producing technical samples. Clinical trial and testing materials may be manufactured by external partners.
Harro Höfliger’s specialists in Process Engineering always pay attention to the entire process. You will therefore receive assistance with questions on all matters relating to the areas of assembly, packaging and web processing. Our consultants are experts in the area of surgical suture material – in all stages from laboratory to mass production. Our team is always available to those pursuing the goal of high process and product quality.