Dirgeshkumar Patel Email & Phone Number

Ahmedabad, Gujarat, India

Antalya Analytical Solutions is coming soon with an advanced and independent laboratory in Ahmedabad. With having highest Quality Standard, we will provide exhaustive range of testing with high accuracy and precision. We strive to set new industry benchmarks to offer analytical services in pharmaceutical sector. Having dedicated and experienced scientific team with state-of-the-art facility to ensure quick turnaround time with high quality standards to meet regulatory requirements.

Ahmedabad, Gujarat, India

-Bridging activities for Product development specially in the field of Niche formulation, Contract Manufacturing Organization managements including quality oversite and Contract Testing Laboratory managements including quality oversite.- Providing scientific consultancy services for Innovative Generic Drug Development, Process Simplification, Productivity Improvement, Quality culture transformation, Training, System simplification and - Auditing Third Party Vendor Audits Investigation Audit Pre-Post Regulatory Audit Gap Assessment Audit QMS Audit- Cosmetic product development and Marketing- Neutraceutical product development and Marketing.

Ahmedabad, Gujarat, India

Quality Compliance Gap analysis, Risk Assessment & Remedial activities Auditing Quality Improvement Program initiatives Strategic compliance training & Inspection readiness Quality Management System Enhancement. Providing the direction to the various type of investigations Provide service to Analytical methods development and AMV. Expert in creating critical SOP's Customers from domestic and global pharma.

Ahmedabad, Gujarat, India

Main leader/contact for Launch New Product Development projects in India while being responsible for all their Quality Assurance aspects,Ensures that relevant GMP training is provided, recorded and updated for all India’s employees,Supports other quality systems such as change control, investigations, etc.Acts as the main contact for all Clarifax from Health Canada,Manages submission dossiers to be provided to Health Canada,Responsible for managing the Third-Party supplier system to ensure that documentation required by regulations is available, up to date and reviewed,Assists in release of product batches into the Canadian market place,Leading JAMP India QA team having 30+ persons for Pre and Post NOC.

Mumbai Area, India(Kenpack Pharma Pvt. Ltd.)

Responsible for Global QA activity as mentioned below for the India facility as well as US facility (Axar Pharma)Creating systems in compliance with the principles of data integrity and equipment compliance with 21 CFR Part 11.Performing audits for API & CMO, CRO and CTL facilities as per cGMP Compliance, Audit Compliance Review, CAPA response & Tracking and assisting CMOs during external audits/inspections to Support Quality Due Diligence and Routine Quality.Responsible for Quality and PAI’s at CMO as well as provide support during the tech transfer and E-batch manufacturing and Validation batches manufacturing.Establishing Quality Management Systems and in compliance with good industry practices; conducting training on cGMP & Regulatory Requirements; Ensuring compliance of query from regulatory authorities such as Information Request, Minor, Major, Complete Response Letter & so on and adherence with the commitment made to regulatory authoritiesReporting quality system performance metrics & trends to assist in decision-making and taking proactive targeted actionsEnsuring in-process controls are performed during manufacturing operation and during the process validation.Reviewing laboratory testing of components, containers, in-process materials, packaging materials and drug product against the predefined acceptance criteriaReviewing complaints to determine if it relates to a failure to meet specification, if so, investigating and reporting to FDA if it is serious and unexpectedGuiding members for investigations on incidents, deviations, out-of-trend and out-of-specification results; reviewing PDR against the development records of F&D and ADLApproval of AMT/Validation Protocols & Reports, Master batch records, Stability Protocols & Reports and Technical & Quality Agreement Documents of External Laboratories & Service ProvidersEstablished Good documentation practices at both locations with proper training and education

Mumbai Area, India(Kenpack Pharma Pvt. Ltd.)

Mumbai Area, India

Ahmedabad Area, India

Spearheading two section of Quality Assurance, Analytical QA and QMSExperience to deal with various regulatory audits like-US FDA, ANVISA, Europe, all were cleared and USFDA with Zero 483.Provide direction to conduct the investigation on laboratory incidents, deviations, out of trend (OOT) and out of specification (OOS) results and ensure timely closer. CAPA monitoring.Ensure quality management system (QMS) compliance across the organization as per the current GMP requirements / industrial practicesTrending of various QMS activities for control and better compliance.Approval of Standard Operating Procedures, Specifications, Standard test procedures, General test procedure (GTP) and Protocols of Quality control departmentApproval of all Quality management systems records of Quality Control department and Quality Assurance.Approval of COA of products to facilitate the release of the products to the market.Approval of analytical method transfer protocols and reports & Stability Protocols and ReportsImparting training on quality management systems and procedures to QC department personnel and QA team membersAudit, Review and approval of Technical and Quality agreement documents of external contract testing laboratories and service providers supporting analytical activitiesAudit, Review and Qualification of API Vendor as per ICH Q7To ensure the Good documentation practices in the Quality control department.Achievement : Make the smooth operation of both the foe all time ready for inspection and resultant all the regulatory audits cleared without and concern. WHO auditor impressed with our trending documents.

Ahmedabad Area, India

Spearheading two group,which is Analytical Method Development and Central Documentation CellAnalytical Method Development: Heading the Analytical Method development team for all the product and Markets.Headed Central Documentation: Preparation, Review and Archival & Control of Specifications/Test procedures/General test procedure of the company for all the locations across the Globe.Experience to deal with various regulatory audits like-US FDA and Europe, USFDA cleared with Zero 483.Achievement: Major contribution to make both the group online with respect to clearing long pending activities,like pending revision and review.

Paonta Sahib

Spearheading Commercial Stability(QC) having team of 23 of commercial stability department. ( 1 for doc cell, 1 for stability sample management, 3 reviewer and 18 analyst)Responsible for overall stability operation of commercial batches from Sample management (Charging and withdrawal, reconciliation of samples), Planning of Analysis, Data Reporting, Investigations Document control, Audit handling and Support other departments with respect to regulatory requirement. Handling different types of investigation, like laboratory incidents, deviations, OOS, OOT, Incident, Deviation, Root cause analysis, Implement CAPA etc...Expertise in handling with various regulatory audits (MHRA, TGA, WHO, Poland, Irish board, Canada, Irom and ANVISA) during the period. All the audit were cleared and non of them has critical or warning letter.

Gurgaon, India

Extensive proven experience in analytical method development and validation in line with the ICH guidelines and Analytical Method Transfer to the PlantProficient in quality based evaluation of drug and drug product during development/optimization and stabilitySpecialize in analysis (NDDS) of Pre-oral Extended Release systems like matrix system, osmotic pumps, enteric coated formulation and multi-particulate systems

Baroda

Marketing of pharmaceutical products.

Certification, Lead Auditor Iso 9001:2015

Certified Lead Auditor ISO 9001:2015

M.Sc, Total Quality Management