A Global Top 5 Dermatology firm (with EU HQ) selected MakroCare for RA Services
Adding to the list of Global Top 20 and mid/small size Pharma & Biotech Clients for Regulatory Services, MakroCare has been awarded a project from one of the Global Top 5 EU based Companies that is exclusively dedicated to Dermatology.
- (1888PressRelease) May 14, 2015 - Under this Agreement, MakroCare will be supporting them on several Dossier Management services including dossier preparation, customization and submission management. Work also includes dossier conversion (to formats like ACTD).
MakroCare's Regualtory Affairs Centre of Excellence (RACoE) has helped several clients through its integrated strategic solutions that deliver compliance at reduced costs for sponsors. This approach offers clients to increase productivity, higher flexibility and lower oversight in cost-efficient manner.
MakroCare's success is a journey of over 15 years with their clients providing a broad range of knowledge-based contract research and consulting services to the worldwide pharmaceutical, biotechnology, and medical device industries.
Since the inception, MakroCare has successfully helped clients launch products or expand into newer regions. We have Services including Regulatory Strategy for getting product approvals globally and to maintain compliance. By effectively "productizing" knowledge and experience in the form of Regulatory Affairs Center of Excellence (RACoE), MakroCare has helped clients accelerate their projects and save costs. MakroCare's Multi-Dimensional Regulatory Service Accelerators (NAVA) are helping companies to pick up the pace of their Global Submissions and receive faster Approvals. In addition, our functional services include CMC Authoring, global submission management, LCM, Labeling & Affiliate support.
In this environment of rapid change and ever increasing demands, companies need to work smarter than ever before, especially in the global arena. Regulatory partnership is a key strategy that can help Pharmaceutical, Biotechnology, Medical Device, and Nutraceutical companies to focus on their core competencies and innovations. MakroCare consulting services offers a comprehensive portfolio of Regulatory services, which comprises of best practices and solutions.
With over 15 years of rich experience, we can help you solve the Regulatory puzzle with innovative and customized solutions. We have a strong team of dedicated professionals with many years of industry and agency experience, who can tailor the project plans to meet different regulatory requirements. We have built a successful track record of timely and extensive approvals.
• Regulatory Strategy
Local regulations & compliance requirements
Product Classifications
Data requirements
Approval Pathways
Design controls consulting & implementation
• Regulatory Writing
Product Approval /Marketing Application
510K, PMA, CE Marking consulting, Emerging and ROW market applications
Technical Files & Dossiers
Plant master files, device master file, etc.
Clinical Comparison Summaries
Clinical Trial Applications
IDEs, CTAs, Ethics approvals, etc.
Annual Reports / Supplements
Case processing, safety reports, supplements, renewals,
• Submission management
Paper / Hybrid / Electronic Application
FDA, EMA, MHRA, PMDA, DCGI, etc
• Authorized Agent / Establishment Registration
• Device Listing & Licenses Management
• Regulatory Information Management
• Agency Responses & Meetings
• Audit preparedness
• Local & Global Compliances consulting and support
• Quality management Systems implementation and validation
QSRs, CFR part 11, part 820, ISO 13485, ISO 14971, IECs, ASTMs, etc
• Advertising and Labeling compliance; review and design (IFUs, e-Labeling, package artwork, etc)
• Internal Trainings
• Contract RA / QA team
• In-sourcing
Our experts are connected to deliver integrated solutions across US, Europe, ROW, etc. with detailed knowledge of the different local submission processes.
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