We, are a group of young, enthusiastic and experienced pharma regulatory affairs professionals having expertise and rich exposure to the pharmaceutical industries. We are involved in providing Regulatory Consulting Services covering services for prescription (branded/generic, OTC, Nutraceutical products. Etc…)
We support our clients in preparation and reviewing of various documents as per ICH, GCC, ASEAN, CIS, LATAM, Africa and ROW regulatory authorities’ requirements like,
- Technical Documents like Standard Test Method, Standard Test Specification, Batch Manufacturing Report (BMR), Product Development Report (PDR), Stability Data, Process Validation Report, and Comparative Dissolution Profile Report (CDP) etc.
- Preparation and Compilation of Dossier and DMFs.
- Analytical Validation and Verification Report for Raw material, Formulation, Related substances etc.
- Risk Management Plan (RMP), Leaflet, SmPC.
- Expert Report Writing, QoS.
- Regulatory CMC strategy and complete support to CMC queries.
If you are in search of any of the above requirements, kindly get in touch with us. We believe in utmost care, completeness and quality assured work following timelines.
Kindly let us know about your requirements in the below comment section and we will get in touch with you in a while.
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