orphan reach leverages local knowledge and experience to rapidly expedite the regulatory process.
We appreciate the significance of high quality submissions to the relevant Regulatory Authorities and Ethics Committees to ensure that approvals are made in a timely fashion. We understand the complexities and the varying requirements of dealing with the numerous regulatory authorities and ethics committees around the world.
We have experts on the ground in each country which ensures that we have up-to-date local knowledge of the submission process, specific to the country.
teams have successfully completed submissions in some of the most challenging regulatory environments, have a comprehensive understanding of the intricacies of each process and are able to communicate effectively with the relevant agencies and regulatory bodies.
Here are some of the areas orphan reach can assist with:
• Regulatory submission (IND, CTA, NDA, CTD, DMF, ANDA)
• Interaction with Regulatory Authorities
• National / Local Ethics Committee Approvals
• Design and negotiation of site and investigator contracts
• Import/export of Investigative Product (IP), biologic specimens and medical equipment
• Destruction of remaining IMP
• Certification of imported equipment
• Translation services, including back translation and proofreading