Udit Narayan Singh Email & Phone Number

India

Delhi, India

Delhi, India

● Authoring and Reviewing of Registration Dossiers in CTD formats for China and South Africa market. ● Handling of Educe tool for uploading, hyperlinking and publishing of dossier in eCTD format using Educe eCTD tool. ● Assess and communicate potential regulatory risk and propose mitigation strategies for China Market. ● Communicating with China and South Africa client for dossier registration and to resolve the issues during the initial submission. ● Liaising with various departments like F&D, AD, QC, QA, Production, Stability departments for the documents availability as per the CDE China requirement and kick off meeting to meet the timeline. ● Maintaining regulatory database like C-DMF verification from CDE China website, Vendor information and status for easy retrieval.

Vadodara, Gujarat, India

● Authoring and Reviewing of Registration Dossiers in CTD formats using RIMS/ AMPLEXOR for new product submission with ANVISA Brazil. ● Reviewing of CMC documents (Pharmaceutical Development Report including dissolution development and dissolution discrimination, Finished Product Specification, In-process specification, Method of Analysis, Analytical Method Validation Protocol/Reports, Elemental impurity report, Residual solvent report, BMR, BPR, PV Protocols/ Reports, Stability Protocol/ Reports) for Brazil Market. ● Communicating with Sun Brazil team for dossier registration and to resolve the issues during the initial submission. ● Liaising with various departments like F&D, AD, QC, QA, Production, Stability departments for the documents availability as per the ANVISA Brazil requirement and kick off meeting to meet the timeline

Hyderabad, Telangana, India

● Authoring and Reviewing of Registration Dossiers for China ● Response preparation for ongoing projects of China. ● Life Cycle Management (Variation & Renewals) of finished product ● Reviewing of CMC documents (Pharmaceutical Development Report, MFR, MPR, Finished Product Specification, In-process specification, Method of Analysis, Analytical Method Validation Protocol/Reports, BMR, BPR, PV Protocols/ Reports, Stability Protocol/ Reports) China Market. ● Communicating with China clients for dossier registration and to resolve the issues during the dossier screening. ● Responsible for compliance of regulatory functions to ensure the approval packages (AP)/ license particulars (LP) are available to QA & Manufacturing sites. ● Liaising with various departments like F&D, AD, QC, QA, Production, Stability departments for the documents availability as per the CDE China requirement and kick off meeting to meet the timeline.

Noida Area, India

● Authoring and Reviewing of Registration Dossier in CTD, ACTD and Country Specific formats for Submission to Emerging markets including CDE China, Singapore, Malaysia, Philippines and United Arab Emirates (UAE). ● Life Cycle Management (Variation & Renewals - APAC, ME/GCC) ● Liaison with various departments like F&D, AD, QC, QA, Production, Stability departments. ● Communicating with global marketing persons for dossier registration and to resolve the issues during the process of registration, re-registration and variations. ● Reviewing of labeling i.e. SPC, PI/PIL and artwork at regular intervals ● Reviewing CMC documents (Pharmaceutical Development Report, PV Protocols/ Reports, Specifications, MoA, Analytical Method Validation Reports, Stability Data etc.) in harmony with regulatory authority of the desired market in compliance with established standards. ● Responding to queries raised by Agents and Regulatory Authorities within stipulated timeline to facilitate regulatory approval.

Karnal, Haryana, India

Authoring the dossiers of Pharmaceutical Products as per regulatory requirements of countries from Africa region (Cameroon, Uganda, Nigeria and Ghana) as per CTD and country specific format ● Life cycle management (Renewal/ Re-Registration) ● Reviewing of dossier ● Review of specification and testing procedure

Roorkee, Uttarakhand, India

Authoring the dossiers of Pharmaceutical Products as per regulatory requirements of countries from Asia region (Philippines, Cambodia, Myanmar, Sri Lanka and Afghanistan) as per ACTD and country specific format ● Assisting team members for maintenance of documentation systems, including chronology files for client’s requirements and communications with regulatory agencies. ● Reviewing the dossiers prepared by team members before submitting to Authorities/ Consultant