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Skills

  • Analytics
  • Compliance Consulting
  • Management
  • Quality Assurance
  • Regulatory Audits

Services

  • Pharma Professional-Quality & compliance

    $150/hr Starting at $200 Ongoing

    Dedicated Resource

    A Pharma professional with extensive experience in the areas of domestic and international regulations, has over 30 years ’experience in Pharma Industry and is well versed in manufacturing and quality...

    AnalyticsCompliance ConsultingManagementQuality AssuranceRegulatory Audits

About

Pharma Industry - Quality and Compliance expert

A.K.Sekhar is a postgraduate in Pharmacy Operations by training from BITS, Pilani. He has been a senior Pharma Industry professional for over 30 years in Operations, Strategy,
Quality and Regulatory Affairs. He has risen from ranks and has been instrumental in setting up
International Quality standard plants from the green field Phase in large, reputed Pharma companies like Krebs, Torrent, Lupin, Oman Pharma, Eisai India, Apotex, and Jubilant
He has led large teams in all these Companies to successful Operations for stable supply, new business, regulatory inspections (US, EU, MCC, TGA, ANVISA, and WHO Geneva….etc.) on
several occasions and has built robust and sustainable compliance ethics, data integrity policies, continuous improvement of systems. He has immensely contributed to the development of skill
level of teams to meet the challenges of ever changing/evolving systems. He has a deep understanding of complexities in related functions of Pharma business like Development, Manufacturing, and Marketing/customer expectations, which helps in taking a 360 degree approach to finding solutions to complex problems.
Has knowledge of relevant drug laws, such as those regarding drug patents, the drug manufacturing process, trademarks, etc. Aware of local drug laws, as well as all governmental polices on drugs. Has comprehensive understanding of drug development phases, generic drug development, and the regulatory process. Develop and implement strategies, identify and close new business contracts, and build and maintain customer relationships. Initiate the development strategies on an account by account basis which meet the needs of the company strategic plan, consistently growing in specific accounts.
His core competence has been to evolve QbD approaches during Development & Regulatory Filing of Dossiers, efficient, affordable and stable supplies to various markets. Efficient deficiency management, Life cycle management of products, Development of robust and Sustainable

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