Sankaranarayanamoorthy M

General Manager (Technical-Operations)

Educational Qualification: M.Pharm (Pharmaceutical Technology)

Biography

A pharmaceutical professional with 24 years of experience in the Pharmaceutical and Healthcare Industry, Sankaranarayanamoorthy has held senior positions at various Pharmaceutical companies handling Technical Operations for the products supplies for Domestic & International Markets.

  • Sankaranarayanamoorthy was instrumental in setting up Core production operations in Finished Products (FP). He is an accomplished Technical professional with a proven track record of establishing higher regulations of Pharmaceutical Industry.
  • Supported on many regulatory audits like USFDA, EU-GMP, MHRA, ANVISA, WHO-GMP and other regulatory standards for Finished Products (FP) especially Oral Solid Dosages of various markets like US, EU, ANZ, Brazil including India market.
  • Sankaranarayanamoorthy plays a major role in production field and CMO in companies like Tablets India Ltd., Alkem, Wockhardt, Glenmark, Actavis and Cipla.

Ravi Kumar

Senior Vice President (Business Development & Alliance Management)

Educational Qualification: M.Pharm (Pharmaceutics)

Biography

Ravi Kumar has over 22 years of experience in the pharmaceutical industry, has strategically partnered and commercialized more than 100 specialty drug products, and is credited as a business pioneer in generic pharmaceuticals. Ravi has both a Bachelor's and a master's in pharmacy.

As a Vice President of Business Development at SanSphere, Ravi created opportunities and strategic partnerships with global pharmaceutical companies. With over two decades of experience in the pharmaceutical industry, Ravi has a proven track record of delivering innovative solutions, driving operational excellence, and enhancing customer satisfaction. He leverages his skills in new business development, process improvement, and strategy to create value for SanSphere and its clients while aligning with its mission of providing high-quality and cost-effective drug products. Previously, he was the Vice President of Business Development and Alliance Management at NECS Pharma, where he successfully managed multiple alliances and contracts with key stakeholders and partners. He is passionate about finding and fostering collaborative relationships that advance the field of pharmaceutical manufacturing and benefit patients and society.

Sundar G

Director (Quality Assurance and Compliances)

Educational Qualification: M.Sc(Chemistry), PG Diploma in Industrial Water & Waste Water Treatment and DCA (Computer Applications).

Biography

Sundar G is developed a profile as quality practitioner with 30 + years of experience in USFDA/EU/PIC(s);WHO-related expertise with Good Manufacturing Practice (GMP) regulations, Quality System Regulation (QSR) and Part 11;EU GMP Annex 11 regulations in leading the Total Quality Management as per cGMP, GLP, GCP in concordance with current USFDA, EMA,MHRA, PIC(s); UK MHRA;TGA;MCC WHO-GENEVA-PQP; ANVISA and PMDA Japan authorities guidelines for the Good Manufacturing of products and services of Pharmaceutical industry including API and Dosage form(OSD and sterile).

  • He is an instrumental on establishing QMS in Medical devices (ISO13485); Food Standards; Nutraceuticals; Supplements and ISO9001QMS.
  • He plays a major role in compliances in Bioequivalence studies GLP/GCP and having high exposure in QA of complete bioequivalence studies and certified Auditor BA/BE and GCP studies (USFDA; EMA; WHO; ANVISA; GCC and ROW)
  • He is passionate to own in leadership for acquiring new accreditations to its break free maintenance with remediation for the audit and compliance for the organization from various regulatory authorities for the clients.
  • He is well versed with the current regulatory requirements; a good trainer cum executer coach for making team ready for audit and compliance in ALL THE TIME READYNESS (ATR).
  • He is an expert in Data integrity Audits and solutions provider.

Guru Prasad

Director (Regulatory Affairs)

M.Pharm

Biography

Guru Prasad has over 20 years of experience in industry and regulatory affairs domain. So far he filed more than 100 Dossiers to regulated markets and more than 1000 Dossiers to non-regulated markets. He worked in renowned companies like Aurobindo, Actavis, Par, etc.

  • He is an instrumental on review of documents for filing in USFDA, EU, and ROW markets.
  • He is passionate to ensure that quality standards are met and that the deliverables meet strict deadlines and fulfill United States, European, ROW, and quality standards. He is an expert in GAP analysis evaluation of CTD and eCTD modules and Troubleshooting of filed dossiers, supporting query response and providing inputs on quality standards/regulations.

Aniruddha kumar

Director (Quality and Analytical Development)

Educational Qualification: M.Sc

Biography

Aniruddha kumar serve as a leader and expert in analytical development for various pharmaceutical dosage forms (oral solids, semisolids, liquids, and parenteral drug de-livery systems); He providing strategic and scientific guidance and technical support to the R&D division. Mr. Aniruddhakumar is responsible for the CMC analytical develop-ment of primarily small and also potentially large molecules drug products.

He supports various NDA/ANDA product developments from project initiation to commercialization, provides technical support to facilitate “First-to-File” and “First-to-Market” company’s goals for US and global markets. He is also re-sponsible for safely and effectively developing, establishing, and validating analytical testing methodologies to control raw materials, production interme-diates, and final products; ensuring all analytical testing activities are in com-pliance with applicable compendia and FDA/ICH regulatory guidance. Aniruddhakumar interfaces with key partners include R&D leaders, CMC-Leaders, supply chain platform leaders, Quality Assurance, Global Regulatory Affairs, and Discovery. He provides scientific guidance on complex manufac-turing investigations and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results, and ensures data integrity.

Sankari Raj

Executive Director, Human Resources

Bachelor of Engineering

Biography

Sankari brings over 15 years of executive leadership experience in human resources, talent management, and organizational development. Before joining SanSphere, Ms. Sankari served in a non-profit organization to advance awareness of emotional and physical health benefits and, partnering with state and local legislature, improving the lives of veterans and senior citizens.

She has a proven track record in all aspects of Human Resources, office management, program development, and the design and implementation of departmental organizational activities.

Expertise in employee relations, employee benefits and compensation, payroll, management of department staff, union relations, safety, recruitment, personnel policies, organizational development, communications, compliance, and training.