Inhalation

INH BG 0116

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Aedestra, Ltd. 11/F., Rykadan Capital Tower 135-137 Hoi Bun Road Kwun Tong, Kowloon, Hong Kong Tel. +44 7975 619544 Contact: Philippe Rogueda E-mail: philippe.rogueda@aedestra.com Aedestra Ltd. is a pharma R&D company providing full ONIDP portfolio evaluation and costing, development and registration in EU, US, ROW, for novel and generic products. James B. Fink 1525 Seneca Lane San Mateo, CA, 94402, US Contact: Jim Fink E-mail: fink.jim@gmail.com An independent consultant serving the inhalation phar- maceutical and biotech industries. JDP Pharma Consulting, LLC P.O. Box 1127, San Carlos, CA 94070 Tel. +1 650 534 4062 Contact: Jayne Hastedt E-mail: jayne@jdppharma.com Website: http://www.jdppharma.com JDP Pharma provides science-based CMC product devel- opment drug delivery consulting services in the areas of pulmonary (dry powder), transdermal, osmotic and ocu- lar drug delivery technologies. Jolyon Mitchell Inhaler Consulting Services, Inc. 1154 St. Anthony Road, London, Ontario, Canada, N6H 2R1 Tel. +1 519 472 5364 Contact: Jolyon Mitchell E-mail: mitchelljolyon@gmail.com Advice on laboratory testing of inhaled products for quality and providing more clinically-relevant data. Education in the form of webinars or site visits to train laboratory staff. MVIC AB Medicon Village, Building 301 SE-223 81, Lund, Sweden Tel. +46 760 160270 Contact: Ola Nerbrink E-mail: ola.nerbrink@mvic.se Website: www.mvic.se MVIC AB is a full ser vice CRO that of fer s highly specialized inhalation product development, covering the entire value chain from drug discovery, development to Phase II/III. pharmAccel Consulting Kurze Gasse 2 78345 Moos, Germany Tel. +49 7732 258 2200 Contact: Rene Bommer E-mail: consult@pharmaccel.com Website: www.pharmaccel.com pharmAccel Consulting specializes in devices, dispens- ing technology, technical and analytical service, in vitro BE studies, performance characterization for new drug and generic applications (OINDPs) and regulatory docu- mentation for submissions. P/L Biomedical 10882 Stonington Avenue Fort Myers, FL 33913, US Tel. +1 239 244 1448 Contact: Lee Leichter E-mail: leichter@plbiomedical.com Website: www.plbiomedical.com P/L Biomedical is recognized for providing up-to-date knowledge and experience to assist in critical areas related to development, registration and compliance of drug delivery combination products. S5 Consulting P.O. Box 147, SE-247 26 Veberöd, Sweden Tel. +46 416 13510 Contact: Dennis Sandell E-mail: dennis@s5consulting.com Website: www.s5consulting.com S5 Consulting provides CMC statistics specialist services, authoring and review of regulatory documentation, and general strategic and development advice, in particular for inhaled products. Consultants Inhalation JANUARY 2016 3

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