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LATEST CASE STUDIES CASE STUDY Paediatric Conducting a Pediatric Investigation Plan (PIP) at Late Clinical Stage A US based Biotech company was unaware of the EU’s requirement for a Pediatric Investigation Plan (PIP) until their product… CASE STUDY FDA Emergency Response: Getting Ahead of The Competitors A US based emerging biopharma recognized that one of their anti-viral therapeutics being developed for a different indication might also… CASE STUDY Medical Device Taking the Pain out of Clinical Studies for Medical Devices A French based research company were looking for guidance on developing a medical device to ensure MD safety validation. VCLS… CASE STUDY EMA An Integrated Regulatory and Market Access Solution for a Successful MAA A US-based biotech looked for a trusted regulatory partner to: 1) Build and execute an EU regulatory strategy and roadmap… CASE STUDY Orphan & Rare Disease Multidisciplinary Support for a Successful ODD Application A US biopharmaceutical client had to withdraw their ODD application during the COMP’s review procedure, due to the lack of… CASE STUDY Digital health Creating a Regulatory Strategy for Software as Medical Device A mobile diabetes software app for patients with diabetes to assist them in the management of their disease by monitoring… RESOURCES Blog Glossary Presentations Publications Webinars Whitepapers Case Studies ALL OUR RESOURCES GET IN TOUCH --- Afghanistan Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Cook Islands Costa Rica Croatia Cuba Curaçao Cyprus Czech Republic Côte d'Ivoire Democratic Republic of the Congo Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See (Vatican City State) Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Kosovo Kuwait Kyrgyzstan Laos Latvia Lebanon Lesotho Liberia Libya Liechtenstein Lithuania Luxembourg Macau Macedonia, the former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island North Korea Northern Mariana Islands Norway Oman Pakistan Palau Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Islands Poland Portugal Puerto Rico Qatar Rennes st Gregoire Romania Russian Federation Rwanda Réunion Saint Barthélémy Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Martin (French part) Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten (Dutch part) Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and the South Sandwich Islands South Korea South Sudan Spain Sri Lanka State of Palestine Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syria São Tomé and Príncipe Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu USA Minor Outlying Islands Uganda Ukraine United Arab Emirates United Kingdom United States Uruguay Uzbekistan Vanuatu Venezuela Vietnam Virgin Islands (British) Virgin Islands (USA) Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Select your country...* --- Search Engine Conference Referral Social Media (LinkedIn, Twitter) Webinar Neighborhood Event Neighborhood Website How did you hear about us ?* --- Biologic Drugs Cell, Gene and Tissue Therapy Chemical Drugs Classical Medical Device Combination Product Digital Medical Device E-Health/M-Health IVDs & CDx Microbiome-based Products Vaccines Other Product type...* *I have read and agreed to the Terms of Use and the Privacy Policy. 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