At Vigipharma, our regulatory affairs experts provide timely, cost-effective and efficient solutions to your company’s pharmaceutical regulatory compliance needs in respect to drugs, biologics, medical devices, combination products, food supplements and herbal products. We ensure that your pharmaceutical products obtain and maintain optimal regulatory status throughout the products’ lifecycle. Our company will provide support in applications for marketing authorizations, regulatory submissions, variations and renewals. In addition, our team keeps abreast and will guide you on any new/amended regulations, hence ensuring regulatory compliance. Our team is highly knowledgeable in providing the following services:

1. Regulatory Strategy Support
2. Comprehensive electronic Common Technical Document (eCTD) publishing services
3. Representation with regulatory agencies
4. Support with regulatory agency meetings
5. Development and review of Standard Operating Procedures (SOP)
6. Medical devise consultancy services for companies acting as local technical representatives as well as support on regulatory procedures for import and export activities
7. Orphan Drug applications