PHARMACEUTICALS AND MEDICAL DEVICES
Regulatory Advisory Platform – Regulatory-Labeling Expertise – Regulatory Intelligence Solutions
CoPharmMedic Consulting has been founded by a Team of Regulatory and Labeling Experts who have gathered sound understanding and suitable technical skills during decades by working for Global Leading Pharmaceutical and Medical Device Companies.
We efficiently
and confidentially Provide
your Regulatory and Labelling Teams with long term and/or short term support during the development of product,
marketing and post-marketing with Technical support,
Expert Advice structured in three main areas:
Working with us means trust,
confidence and Flexibility as we thoroughly discuss with you in order to shape your temporary
and/or permanent technical and resources needs.
Regulatory Advisory Platform
Our Regulatory Advisory Platform support and advise your Phamaceuticals and Medical Device Teams
- Compiling, or supervising of the compilation and review of regulatory dossiers in accordance with Health authorities´ requirements.
- Support and advise your project teams to ensure regulatory challenges and burdens are planned, delivered and submitted in time to meet projects objectives
- Liaising with relevant stakeholders, associate companies regulatory authorities as required.
- Provide format and contents review of Regulatory documents
- – Take the Lead of your temporary and/or Permanent Projects
Overall advice regarding:
- Procedures for Marketing Authorizations
- Dossiers Submissions
- Strategy and Operations
- Staff Training and Update
Regulatory-Labeling Expertise
Our Labeling Experts support and advise your Phamaceuticals and Medical Device Teams in:
- Coordinating processes for creating, maintaining and updating labels and Labeling documentation(packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling, CCDS)
- Coordinating all kind of product specific labelling‚ existing and new label configurations
- Leading overall labelling projects milestones complying with internal and external requirements (e.g Guidance, Regulations for Medicines, Medical Devices, ISO)
- Coordinating, taking the Lead of your temporary and/or Permanent overall Labeling activities
Regulatory Intelligence Solutions
Our Regulatory Intelligence solutions provide your Phamaceuticals and Medical Device Teams with support and advice in:
- Daily screening and analysis of information in global regulatory landscape Generating newsletters on demand(weekly, monthly…)
- Creating company owned database for Information Management
- Creating company owned database for Information Management
- Providing Training Material for Regulatory and Labeling Teams
- Take the Lead of your temporary and/or Permanent Projects
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Years of experience
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Projects completed
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#Laboratories #Pharmacy #Regulatory advice platform #Labelling expertise #Watch solutions
#labelling #expert group #pharmaceutical laboratories #medical device companies