GBA-PHARMA.COM Your Challenges Require Smart Solutions. GBA PHARMA GmbH Fraunhoferstrasse 11 a, 82152 Martinsried, Germany Regulatory Affairs A service for manufacturers of l Bio- and Pharmaceutical Products l Medical Devices l Packaging Materials for Pharmaceutical Products Further information about our service portfolio can be found at www.gba-pharma.com Our Services: for Human Medicinal Products, Generics, Herbal Medicinal Products, Medical Devices, Veterinary Medicinal Products, Homeopathics l Consulting l Conception of regulatory strategies l Scientific advices l All MAAs (CP, DCP, MRP, NP) l All types of documents (CTD, eCTD, ASMF, NTA, STED, CEP, IMPD etc.) l All CTD modules (1 to 5) l All variations types (IAIN, IA, IB, IB unforeseen, II, line extensions) l Grouping and work-sharing options l Life cycle management l Package leaflets (conception, mock-up, readability user test) l Pharmacovigilance incl. QP service l Cultivar screening of herbal drugs l Due diligence of MA documents in case of purchase options
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
GBA-PHARMA.COM
Your Challenges Require Smart Solutions.
GBA PHARMA GmbH Fraunhoferstrasse 11 a, 82152 Martinsried, Germany
Regulatory AffairsA service for manufacturers of l Bio- and Pharmaceutical Products l Medical Devices l Packaging Materials for Pharmaceutical Products
Further information about our service portfolio can be found at www.gba-pharma.com
Our Services:
for Human Medicinal Products, Generics, Herbal Medicinal Products, Medical Devices, Veterinary Medicinal Products, Homeopathics
l Consultingl Conception of regulatory strategiesl Scientific advicesl All MAAs (CP, DCP, MRP, NP)l All types of documents (CTD, eCTD, ASMF, NTA, STED, CEP, IMPD etc.)l All CTD modules (1 to 5)
l All variations types (IAIN, IA, IB, IB unforeseen, II, line extensions) l Grouping and work-sharing optionsl Life cycle managementl Package leaflets (conception, mock-up, readability user test)l Pharmacovigilance incl. QP servicel Cultivar screening of herbal drugsl Due diligence of MA documents in case of purchase options
Related Documents
