|Majella Ryan||Audrey Butler||Alice D’Alton|
|Emily Fletcher||Nanda Naik||Edel Behan|
The team at Ivowen Limited has extensive experience in the areas of EU Regulatory Affairs and Pharmacovigilance. Our individual team members bring diverse expertise together to solve our clients’ unique problems. Our experience spans 20 years in the generic pharmaceutical industry and covers all dosage forms including tablets capsules, solutions, suspensions, as well as creams, parenterals and other sterile products with a strong emphasis on regulatory strategy. Ivowen’s team has experience managing complicated projects in multiple Member States and has therefore established strong working relationships with regulators throughout Europe. We can provide expert advice in all areas of product development, regulatory strategy, dossier preparation and MA submission through to national phase registration. We can support your licence registrations by advising on the need for variations post-approval.
We can also provide expert pharmacovigilance advice pre and post-approval including the provision of QPPV services. Ivowen Limited has an extensive range of training options available which can be tailored to your company’s needs.