Inhalation

INH0415BG

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Aedestra, Ltd. Unit 2205, 22nd Floor, Causeway Bay Plaza 2 463-483 Lockhart Road, Hong Kong Tel. +44 7975 619544 Contact: Philippe Rogueda E-mail: philippe.rogueda@aedestra.com Aedestra Ltd. is an inhalation R&D company providing ser- vices to pharmaceutical companies wishing to develop and register OINDPs in EU, US, Asian and LATAM markets. 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 pharma- ceutical 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 develop- ment drug delivery consulting services in the areas of pul- monary (dry powder), transdermal, osmotic and ocular 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 service CRO that offers 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 APRIL 2015 3

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