Regulator Services
Submission to Agencies
Whatever, the drug or device, it is important to submit the pertinent data and documentation in the correct format. Ensuring regulatory compliance can help reduce the time to approval.
With our partner Voisin Consulting (LINK) we can help you implement a regulatory strategy that complies with regulations.
The staff at Voisin has the technical and scientific knowledge to support your efforts in complying with international regulation guidelines, and help you prepare a solid regulatory submission package and strategy.
Both IDDI and Voisin have extensive experience with the FDA and EMEA regulatory bodies.
Voisin has regulatory experience for Phase I, pediatric and medical device submissions.
European submissions, Voisin Consulting was granted SME status by the EMEA in April 2006. Voisin is therefore authorized to represent non-EU small and medium-sized enterprises (SMEs), rendering the provisions for administrative and financial assistance proposed by the SME Office, according to Regulation EC 2049/2005, available to them.
Since 2000 IDDI has helped 14 regulatory approvals