Venkata Shiva

Responsible for all activities in India. Key member of the global strategic team.

Oversee financial planning, budgeting, and forecasting to ensure sustainable growth and profitability. Defined and achieved aggressive revenue targets.

Developed and executed a long-term strategic roadmap for the company's growth, with a focus on scaling revenue and expanding market share.

Manage relationships with investors, partners, and key stakeholders to drive business performance and secure future growth opportunities.

Develop and implement strategies to expand footprint in key global markets.

Lead and manage sales and marketing teams to drive customer acquisition, market expansion, and brand development in the global market. Cross-selling of global services to local companies.

Collaborated with the marketing team for business development, partnerships, and enterprise-level client relationships.

Fostered a culture of innovation, worked closely with product teams and third parties to evolve and expand offerings in line with market demand.

Implemented quality by design, enterprise risk management principles in the product and clinical development.

Collaborated with other C-level executives in developing business strategies.

Co-founder of Bioserve (Employee: 001). Built the organization from ideation. Responsible for Profit and Loss of the organization. Reporting to the board of directors.

Responsible for all activities, including marketing, product development, clinical research, human resources, and finance operations.

Developed and implemented strategic B2B business to expand services. Developed annual marketing calendar.

Participated in several international pharmaceutical business events, including CPHI, GIA, AOAC, and GPhA.

Established B2B relationships to secure product development and clinical research business opportunities with global pharmaceutical, biologics, and medical device manufacturing.

Collaborated with innovator and product development companies to develop their generic products in India.

Developed leachability and extractability testing services for global pharmaceutical companies.

Lead the team in 30+ regulatory inspections (USFDA, WHO, MHRA, EMA, and ISO).

Responsible for business transformation from non-regulatory markets to highly regulated markets. Contributed to the development of a strategic business plan for drug products and substances.

Collaborated with senior management to design and establish six (6) modern, green manufacturing products for sterile and non-sterile drug product and substance manufacturing.

Developed internal packaging materials design and manufacturing operations, including ISO 15378 certification.

Collaborated with senior management, research, and marketing to identify future projects for the development of generic drugs for developed markets (US, Europe, Canada, and Australia).

Collaborated with marketing and research teams, and supplier, to discuss packaging specifications for all products, for all markets.

Meeting with the design and marketing teams to discuss packaging specifications and confirm budgets.

Lead the team in 30+ product technology transfer, process validation, and commercialization.

Lead the team in preparation and review of 100+ regulatory dossiers, and handling regulatory queries.

Lead the team in 25+ regulatory inspections, including USFDA, WHO, EMA, MHRA, and ISO.

Established a robust compliant handling procedure and processes.

Implemented continuous improvement processes, including Business Process Re-engineering, Six Sigma, and total quality management, in the business operations.

Implemented statistical quality control in the operations. Built KPIs and Dashboards using Excel.

Established quality management system in multiple manufacturing and research facilities.

Management representative for all 15+ ISO inspections.

Establishment of a quality management system.

Contributed to 20+ product technology transfers, process validations, and commercializations.

Vendor development, qualification, auditing, and evaluation of 200+ vendors (packaging and critical raw materials).

Contributed to 10+ regulatory inspections in drug product and substance manufacturing.

Lead the team in internal quality audits planning, conducting, reporting, and closure.

Contributed to the preparation, submission, and handling of regulatory queries for 30+ marketing dossiers.

Testing of packaging and raw material for drug product manufacturing.

Prepared technical specifications for packaging, raw materials, and finished products.

Prepared and reviewed analytical testing methods for packaging and raw materials.

Collaborate with cross-functional teams to ensure packaging solutions meet product, regulatory, and market needs.

Work with suppliers and product development teams to ensure the feasibility of designs.

Conduct research on materials, technologies, and trends in pharmaceutical packaging.

Developed and validated 20+ analytical methods.

Contributed to long-term stability for 20+ products.

Contributed to 8+ regulatory inspections (Russia, EMA, USFDA, and ISO).