CONTENTS
- 1. Pharmaceutical·Bio | Industrial
- - Features of Industrial Structure
- - Venue Map
- 2. Pharmaceutical·Bio | Major legal·Government risk
- - Patent litigation and intellectual property rights issues
- - bidding/marketing status issues such as abuse
- - Regulations such as license, GMP, clinical trials
- - Copyright (c) 2015 SHINSEGAE. All Rights Reserved.
- - Research and import food safety management
- 3. Pharma·Bio | Risk Management
- - Support & Support
1. Pharmaceutical·Bio | Industrial
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ie, approval of trial; acceptance, Separate regulations are applied at each stage, such as GMP examination, determination of drug prices and reimbursement standards.
Accordingly, patent strategy (including license-patent linkage) and fair trade (reverse payment agreement, market dominant position) are law-compliant. Review, comprehensively design insurance listing strategy (compared to HTA/economic evaluation), M&A IPO A comprehensive response to legal risk management of process. News /span>
Features of Industrial Structure
Pharmaceuticals·bio companies have the following characteristics: News /span>
Innovative product competition, patent litigation, Inconsistent settlement, Market ground status Nam-yong, etc. Fair trade issues are frequent
inconsistent
Venue Map
Pharmaceuticals·bio market is >With the structure of strengthening and innovation promotion policy, simulation standards·authorization system·insurance·precision system is fast.
Specification of the use of digital health data, Elongation of prolongation of prolongation management, PVA the realization of post-management is core flow. News /span>
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2. Pharmaceutical·Bio | Major legal·Government risk
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< 75%, 60%);">Research development, Research, Production, Sales, Insurance strategy etc. All stages of the regulation risk occurs.
In the trial phase, IRB approval, Clinical Trial Plan (IND) approval, We are required to comply with legal proceedings such as the CAT agreement, If you have any questions, please feel free to contact us. News /span>
Data Transfer, The key provisions such as results reporting obligations must be clearly stipulated and may prevent future disputes. News /span>
statistical and mathematical feasibility, If there is a lack of GMP conformity, it may be delayed or repaid, so it is important to establish a pre-strategist. News /span>
Patent litigation and intellectual property rights issues
In the process of reagents and reagents, patent invalid/determined suits, permission-patent linkage will appear as core competencies. News /span>
Specifically Reverse settlementIf the competitiveness of Reverse settlement and pre-determind. News /span>
News <% var comment path = (typeof window == 'undefined') ? '/fcv/tpl/comments/' : ''; list = list.reverse(); var showMore = (comment.total cnt > 3) %> In case of excessively limited access to the drug market, it may be problematic with fair trade laws and competitions. Pre-risk check is very important.
bidding/marketing status issues such as abuse
News /span>
In addition, if the share of certain medicines market is high Marketing Status Abuseto be easy to issue, Process responses directly affect the business continuity of the company. News /span>
Regulations such as license, GMP, clinical trials
Pharmaceuticals·biopharmaceuticals·Health functional foods·Pharmaceuticals for animals must be authorized/consistent/consistent in food safety, precision tests from quality control (GMP), accuracy requirements must meet the legal requirements in all processes. News /span>
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precision test phase
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In addition, In case the core provisions such as the subcontract/delete range, etc. may lead to test interruptions or disputes, formative responsibility. News <% if (imgObj.width >= imgObj.height) { %> <% if (image rate > 5) { %> <% if (image rate > 5) { %>
When Advance quality and screening strategies can increase the chance of success.
In addition, after permit, the conditional permit fulfillment, Safety information report, Safety etc. follow-up regulation, so you should be integrated to the management system after authorization. News /span>
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Copyright (c) 2015 SHINSEGAE. All Rights Reserved.
PVA(Capacity–Medicine Interlocker) Complex, Expansion standard extensions are directly connected to the marketability of the product. News /span>
especially stability revaluation requires continuous response, which can lead to an existing product's weakness or deduction. News /span>
Research and import food safety management
Pharmaceuticals·bio·food companies may be subject to the following investigations and practices: News <% var comment path = (typeof window == 'undefined') ? '/fcv/tpl/comments/' : ''; list = list.reverse(); var showMore = (comment.total cnt > 3) %> News /span>
3. Pharma·Bio | Risk Management
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Support & Support
The medical/bio/healthcare group of the main corporation is R&D–prevention–appropriate–appropriate–insurance–market, Competitive–appropriate–appropriate advisory across industries until M&A·IPO. News <% var comment path = (typeof window == 'undefined') ? '/fcv/tpl/comments/' : ''; list = list.reverse(); var showMore = (comment.total cnt > 3) %> GMP, Quality management, Providing compliance systems such as life ethical law and compliance advisory
Establishment of administrative investigations·consumer response strategies such as dietary and fair support
pet health care products; News /span>
We understand the industry's regulatory structure and corporate operating environment, We provide practical advice on various issues such as inappropriate human rights, product management and marketing. News /span>
In the complex regulatory environment of the drug·bio industry, internal style="color:black;"> News /span>
