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 Services include, but are not limited to:
Regulatory strategy
Risk management & Mitigation strategies
Regulatory submission (FDA, EMA, MHRA, PMDA, DCGI, etc)
Regulatory writing
Compilation and Preparation of Dossier/DMF in CTD/eCTD format
CMC, Non-clinical and Clinical Writing
Reports (ADI, PSUR, etc.)
eCTD capabilities
Labeling
Our experts are connected to deliver integrated solutions across US, Europe, ROW, etc. with detailed knowledge of the different local submission processes.
Consulting(End-to-End)
Regulatory Strategy
Regulatory Submissions
Regulatory Compilance
Risk Management