+91 9167857580 binal@q3healthcare.com

Pharma

Consulting

Q3 Healthcare’s consulting services help pharmaceutical companies achieve Quality and Operational Excellence, improve profitability, accelerate growth, adopt GMP (Good Manufacturing Practices) guidelines, and obtain local and international regulatory approvals.

From start-ups to large organizations, we partner with clients to transform their organizations in the following ways:

OPERATIONAL EXCELLENCE

Leveraging our vast experience of improving processes to help transform companies into systems-drive, process-oriented organization, we help our clients undertake initiatives such as OEE (Overall Equipment Effectiveness), Plant Performance Improvement, Capacity Enhancement, present-state assessment (diagnostic analysis), benchmarking, shutdown maintenance and turnaround improvement processes. Furthermore, we enable pharma companies to strengthen their manufacturing operations and implement inventory management through strategic planning. For example, we worked with a Rs-500-crore ($70 million-plus) pharma company to bring about a transformative shift from people-driven to a systems-driven organisation by introducing processes and training modules.

Our team of consultants and technical staff go well beyond consulting and advisory to drive all the initiatives with on-site presence, wherever necessary, to ensure that all the objectives and goals are achieved.

QUALITY MANAGEMENT SYSTEM (QMS)

We are actively involved in design and implementation of Quality Management Systems (QMS) at pharma companies. We ensure strict adherence to all the policies, processes and procedures required for planning and execution of production and development of pharmaceutical products, suitably aided by the QMS.

We possess an in-depth knowledge of validations, compliance management, technology transfer and CAPA Management. We impart training on quality standards, and conduct stability reviews for our business associates.

EXPANSION AND GROWTH

Armed with the experience of overseeing more than 150 pharma manufacturing plants, we help our business associates achieve scalability and faster growth. With our experience of managing and improving all the functions of an organization like drug development, operations, quality assurance, licensing, regulatory compliances and production, we have helped small-scale enterprises become mid-sized, and mid-sized enterprises attain the size and growth of a large organization by bringing about a system-driven transformation.

REGULATORY AFFAIRS

We have a proven track record of successful liaising with Indian and international regulators such as India’s Central Drugs Standard Control Organization (CDSO), Australia’s Therapeutic Goods Administration (TGA) and the UK’s MHRA (Medicines and Healthcare products Regulatory Agency) for compliances with best-practices guidelines such as Schedule M of Drug and Cosmetic Act 1940, World Health Organization’s GMP (Good Manufacturing Practices), and for regulatory filings, auditing and approvals.

In essence, we help partners implement GMP guidelines, ensure successful international audits, and obtain regulatory approvals.

COLLABORATIVE GROWTH

India’s pharmaceutical industry has been witnessing a healthy rate of growth since the turn of this millennium. It means that large pharma companies, with turnovers of over Rs 500 crore ($70 million plus) are looking to partner with contract manufacturers who have the requisite technical and quality-compliance capabilities and regulatory approvals in place and vice versa. Our industry-wide network and longstanding relationships with promoters, owners, and senior management personnel of more than a hundred manufacturing companies ensures that we are able to provide our clients with numerous networking opportunities and avenues of collaborative growth.

We can help your team

We offer customized solutions to various industries. Find out what suits your requirement best.