He assisted many pharmaceutical companies in complying with regulatory requirements and standards set by agencies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency).  

He is involved in: 

• Process improvement by  Identifying opportunities for process improvement, optimization, and efficiency in pharmaceutical manufacturing and quality control processes. 

• GMP (Good Manufacturing Practices) compliance: Ensuring that pharmaceutical manufacturing facilities and processes adhere to GMP standards to maintain product quality and safety. 

• Troubleshooting and problem-solving: Providing expertise and guidance in resolving analytical and quality-related issues that may arise during pharmaceutical development and manufacturing.

• Documentation and reporting: Maintaining accurate records, documentation, and reporting related to analytical testing, quality control activities, and regulatory compliance

Clinical Research Multifaceted professional with above 18 years of experience in managing and auditing BA/BE studies and achieve excellence in the field of Clinical Research in:

Her Competencies include:

● Planning and execution of Method development, method validation and sample analysis activities

● Reviewing all study related documents like protocols, raw data forms and excel data.

● Design and approve documents such as SOPs, quality manual and related documents.

● Preparing reply and compliance to the observations or queries raised in regulatory inspections and sponsor audits

● Reviewing the operational practices, identifying the areas of obstruction / quality failures and advising on process

    changes for achieving qualitative improvement

● Driving forward the improvement of all quality systems including complaints, change control, deviations and

   compliance programs

● Vendor evaluation, selection, coordination with vendor for CSV, Reviewing the process and documentation of

   Computer System Validation (CSV)

● Reviewing pharmacokinetic and statistical analysis

● Vendor qualification and evaluations

● Imparting training to all staff to practice quality procedures

In past Maya had a distinguished career that includes working with esteemed organizations such as Maharshi Ayurveda, Alembic Ltd., and Cipla Ltd., She has established herself as a trusted professional in the industry. 

• She is a certified lead auditor for ISO 13485, highlighting her comprehensive understanding of quality management systems specific to the Pharmaceutical and  medical device industry. 

• Her extensive experience spans the registration of Pharmaceutical, Medical Devices,  Drug-Device Combination Products, and IVD products for both Indian and international markets. 

• She is well-versed in the intricacies of CTD/eCTD documentation for Pharmaceutical and Combination Products, ensuring compliance with regulatory requirements. 

• EXPERTS in Global ICH formats like CTD/eCTD/ACTD/NeeS. 

• Well versed with regulatory strategies of US, Europe, Canada, Australia & emerging Markets, domestic markets registrations and regulatory compliance as per US/EU/PIC/s regulations. 

• Global submissions - ANDAs, USDMFs, European MAs via National, MR and DC Procedures. 

• Compilation and submissions for emerging markets, Liaisoning with CDSCO/ DCGI  offices. 

• She serves as a visiting faculty member at MIP/WPU – MIT Campus in Pune for the Post Graduate Diploma in Regulatory Affairs (PGDRA) Maharashtra. 

• She is associated with IIT Sine, Mumbai Incubation center and Social Alpha incubation center

Very Good experience and exposure as a Regulatory affairs and quality compliance  professional at all levels in the Indian Generic Pharma Companies. 

• Well versed with regulatory strategies of US, Europe, Canada, Australia & emerging  Markets, domestic markets registrations and regulatory compliance as per US/EU/PIC/s regulations. 

• Global submissions - ANDAs, USDMFs, European MAs via National, MR and DC Procedures. 

• Compilation and submissions for emerging markets, Liaisoning with CDSCO/ DCGI  offices. 

• EXPERTS in Global ICH formats like pCTD/eCTD/ACTD/NeS, 

• Faced international GMP inspections for API and formulation facilities. 

• Successfully completed GMP and GLP Audits as per USFDA,EMA/EdQM, TGA, UK-MHRA, ANVISA, WHO, INDIA and respective MoH and local HA. 

• EXPERTS in getting Approvals for IND, NDA, ANDA, GENERICS, & API (DMF/ASMF/CEP-CoS), Finished Products. 

• Supported clients in Audits/Inspections, Validation and Compliance activities to avoid  483 and warning letters. 

• Also, active participant and speaker at IDMA, DIA and various Regulatory and  Compliance events.

• Approx. 150 EU MA submission procedures as per EU regulations (MA-Marketing  Authorization) 

• Approx. 70MAs to TGA, Australia with Pre-submission and complete filings. 

• Approx…1000 APAC, SEA / Latin America, Russia / CIS and sub-Saharan African and South African filings. 

• For Oral solids, Topical/ semi solids, Onco injectable & low volume parenteral – aseptic filling and Terminal sterilized vials, ampoules and PFS etc. 

• Approx. 70 US Type II DMFs in paper and NeeS formats. 

• Compiled and submitted more than 100 EDMF applicants and Restricted EDMFs for EU, Australia, Singapore, and South Africa. Compiled and filed more than 100 CEP applications.