EU client selected MakroCare for Labeling project
A leading EU based biopharmaceutical company approached MakroCare for designing and reviewing of FDA compliance Labeling material in Oncology. This consulting service was handled mainly using MakroCare regional labeling team for designing the materials covering all the scientific, clinical data and benefits of using this novel therapy over the existing which is required to educate the experts attending the congress. Given the stringent time lines by client and as indications vary by country we used our Medical & Regulatory experts to complete this consulting work in given timelines so that client can advance their product to experts around the globe
MakroCare Labeling department has in depth experience in Medical & Regulatory Affairs, offering strategic & tactical, innovative value-added & operational services to companies tailoring client needs to meet different regulatory requirements.