Marketing Authorization Regulatory Submission
PLG provides 360-degree life sciences consulting support in the preparation of the Common Technical Document (CTD) in compliance with harmonized guidelines for global submissions, such as those of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), as well as good documentation practices; and in accordance with country-specific requirements. Our support includes handling the electronic or digital and/or paper marketing authorization submission, as required by each country; managing the evaluation process; giving timely responses to deficiency letters from health authorities; dealing with the marketing authorization approval process; conducting national submission management across all phases of the product life cycle, and seeking price and reimbursement approvals.
Detailed services:
European Union
- European Union electronic Common Technical Document (eCTD) preparation and publishing
- European procedures management: Centralized procedure, decentralized procedure, mutual recognition procedure, national procedure, and repeat-use procedure
North America
- eCTD for drug application
Latin America
- Dedicated product master file with translations of required modules
Asia Pacific
- Dedicated product master file with translations of required modules
Commonwealth of Independent States
- Dedicated product master file with translations of required modules
Middle East and North Africa
- Dedicated product master file with translations of required modules
South Africa
- Dedicated product master file with translations of required modules
Complementary Services
- Artwork and labeling preparation and translations
Life Cycle Management
Marketing authorization approval represents the start of a journey for a product, which will go through continual updates and changes during its life cycle. These ongoing development processes require product variations and renewals, which places significant demand on marketing authorization holders (MAHs) and distributors with regard to keeping track of and complying with different global regulatory requirements.
PLG offers global product life cycle management services to ensure MAHs and distributors comply with regulations worldwide.
The services are:
- National life cycle management
- Product variations (major, minor, separate, groupings)
- Product renewal
- Market authorization transfer;
- Cancellation of marketing authorization
- Complementary services: Artwork and labeling reviews and translations
- Support of local market for product launch
- Preparation of companies for inspection by health authorities
Contact us to learn more about our services and how we can help your firm keep your products up-to-date with regulations.