Skills

Having working experience of around 20 years in various spheres of the Pharmaceutical world i.e. Global Regulatory Affairs, Quality Compliance, and Analytical Research & Development. Has worked extensively in the field of Global Regulatory submissions, dossiers compilation, and registration of generic drug products for regulated markets (especially Europe, USA, Australia) and Emerging Markets (ROW).

Global Regulatory Services

Ø  Compilation, Authoring and Review of Dossiers/DMFs/CEPs across the globe and Regulatory Submission Publishing

Ø  Electronic Drug Establishment and Product Listing through U.S. FDA Electronic Submission Gateway.

Ø  Regulatory Compliance

Ø  Gap and Risk analysis

Ø  Handling Variations, PAS, CBE, Annual reports and Renewals,

Ø  EU -QP service

Ø  Dossiers for ASEAN / ROW countries as per country-specific format

Ø  SPC/SmPC, PIL and Labeling

Ø  Support in query responses for Dossiers / DMfs.

Ø  Pre-clinical and clinical services

Ø  Medical writing

Ø  Art-work designing

Ø  Pharmacovigilance services

Ø  Translation services

Ø  Patent compliance services

Ø  Regulatory Audits  evaluation 

           Compliance Services

Ø  Hands-on involvement in quality system development and implementation of systems and procedures to ensure

Ø  Technical and strategic support in responding to deficiencies / inspectional observations letters.

Ø Preparation and review of plant and equipment qualification master plans and protocols.

Preparation and review of the process and cleaning validation protocols.

Ø  Technology transfer and strategic regulatory advice on change control, process changes, and site transfers.

Ø  Analytical method transfer and validation activities.

Ø  Aseptic Processing and Validation Program Evaluation.

Ø  GMP Documentation

Refrences

worked for Multi-national projects, Submission of ANDs, DMFs, EU dossiers and other emerging markets. Could establish pharmaceutical industry to meet the regulatory requirements. 

Time and Spatial Flexiblity

remote working , flexible timing 

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