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

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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