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Vilas Beloshe

Vilas Beloshe

Quality and regulatory specialist

Services provided: Medical Devices Experts

Healthcare

Dunstable, Central Bedfordshire
£40 / hour
Approximate rate

Social

About Vilas Beloshe:

• Expertise in implementation of ICH guidelines for product development and process improvement

• Strong hold on CMC submissions for Pharma products which includes post-approval activities and new filings.

• Experience of post approval submissions like EU- Type IA, Type IAIN, Type IB and Type II for MRP/DCP and National Procedures

• Support health authority questions during licence change maintenance submissions.

• Experience in handling customer and health authority inspections

• Supportive process improvement changes

• Experience in handling various regulatory databases.

• Review, preparation, compilation, and submission of different variation packages to various regulatory authorities

• Expertise in EU MDR technical file maintenance

• QMS, Internal Audits, Process Validation,

• Batch release,

• Equipment and software Qualification

• Computer System Validation.

Experience

• Expertise in implementation of ICH guidelines for product development and process improvement

• Strong hold on CMC submissions for Pharma products which includes post-approval activities and new filings.

• Experience of post approval submissions like EU- Type IA, Type IAIN, Type IB and Type II for MRP/DCP and National Procedures

• Support health authority questions during licence change maintenance submissions.

• Experience in handling customer and health authority inspections

• Supportive process improvement changes

• Experience in handling various regulatory databases.

• Review, preparation, compilation, and submission of different variation packages to various regulatory authorities

• Expertise in EU MDR technical file maintenance

• QMS, Internal Audits, Process Validation,

• Batch release,

• Equipment and software Qualification

• Computer System Validation.

Education

Masters in formulation science 

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