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Qualiculture Consulting Group: serving the community by advancing translucent quality culture in healthcare

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Qualiculture Consulting Group: serving the community by advancing translucent quality culture in healthcare

QualiCulture Consulting Group creates a system to balance regulatory requirements and business outcomes and strive to be most admired consulting partners for Indian Healthcare System.

In the past few decades, there is huge growth in the Indian Pharmaceutical Industry, but there are numerous challenges as well. As the industry has expanded to commendable heights, with an increase in the product portfolio, volume, and global presence, the complexities have also increased, affecting the quality of the product.

The issues faced by the industry varied from the performance of product, facility, systems to Data Integrity hurdles. With the incorporation of more products, an increase in volumes, procedures were not simplified in line with exact practice or exact requirements, often leading to errors in execution. The deployment of automation through IT systems has created the transparent backend data archival which added to the complexity.

Additionally, in this phase, the country was witnessing a high level of regulatory challenges in terms of GMP compliance at manufacturing sites and the gap in understanding of the regulatory expectations. There was indeed a great demand for a proficient expert who can present a complete solution range to the industry and facilitate in inculcating the culture of quality and compliance across the industry.

In 2016, QualiCulture decided to enter in cGMP and remediation consulting, to cater to small and medium-size Pharma companies and support them in expanding their business with reasonable spend on expert support. The company delivers a comprehensive solution for GMP and regulatory compliance to Pharmaceutical, Biotechnology, Biologics, and Medical Device industry. Today, the wide range of subject matter expertise, compliance and regulatory strategizing skills and association with agencies as well as industry forums, makes QCG the best in the industry thereby to act as a catalyst in compliance journey of clients. It is offering the best consulting services for addressing the issues of Pharmaceutical, Biotech, and Medical Device firms.

Services under the Hat of QCG

QCG is focused on providing highly skilled services to the clients at an affordable cost and thus upbringing the standards of the small to medium-sized companies to industry benchmark and to set new benchmarks for the established clients and global players. Here is the list of major services offered by the company:

Pharma Biotech Services

  • Remediation Of Enforcement Actions by various regulatory agencies
  • Regulatory Applications ( DMF, NDA, ANDA, BLA) Review Support for adequacy and completeness
  • Assessment Of Laboratory Controls to ensure data integrity
  • Microbiology And Sterility Assurance using advanced tools like Sterile Product Compliance Risk Assessment ( SPCRA)
  • Inspection Readiness of the sites
  • Remediation Of Quality Systems and establishing Quality Governance processes across the organization
  • Training, Education and shop floor mentorship
  • Due Diligence of the assets during acquisitions or mergers or strategic investments

The Journey from Inception to Present-day

2016: Initiation of QCG (team size 3)

2016: Received first 5 clients including a large company in India

2017: Reached the client base of 10 including 3 top MNC operating in India (Team size: 20)

2018: Reached client base of 20 including 5 top Indian MNC and 5 Global MNC

2018: Crossed 1 million USD top lines for the company (Team Size: 40)

2019: Delivered a project worth half a million USD for a global MNC

Clientele

There are 21 major clients consisting of 5 global MNC and 4 of the top 10 Indian companies.  QCG believes in exhibiting a high level of trust in data and information security and strive to be on a fact-finding mission and not on fault-finding mission.

The company gives its best to highlight problems and provide sustainable solutions to shop floor teams and try to delight clients every time. In order to ensure maximum satisfaction, it hires only top class professionals and technically capable and domain experts.

Team and Work Culture

Qualiculture Consulting Group is a bunch of 40 experienced professionals who are dedicated and passionate about their work and perform in all ways to assist clients.  Partners and senior consultants at QCG play crucial roles in facility set up, establishing Quality Management Systems, regulatory filings; preparing the sites for national and international regulatory agency inspections, handling the inspections and observations, strategizing the remediation, facilitating face to face meetings with regulatory agencies and to formulate a sustainable culture of quality in the organization.

The company also takes care of each employee and support them to stay up to date through regular training and learning. Here, all associates are subjected to regular training related to GMP, current regulatory trends, etc. In addition to the training related to protocol-based activities, regulatory surveillance and associated training are in progress to gather current updates in regulations and GMP requirements and to upgrade employees to prepare them ready as per the updated requirements. Additionally, associates are encouraged to participate in workshops and training conducted by various institutions.

Significance of the Advanced Technologies and Tools

Although the generic pharma business has profitability challenges, BioPharma, biologics, and medical device domain is expanding and is going to be a growth engine for the companies operating out of India.

Milestones and Achievements

  • QCG is seen as an effective, proficient, and viable alternative to top global GMP consulting firms, thereby providing affordable services to clients typically at 20% of the cost against the global consulting firms.
  • The company has developed 3 flagship programs to create capability in pharma shop floor teams, thereby inculcating the culture of ownership and compliance at the shop floor viz investigation Robustness, Internal Auditor capability building, and Sterile Product compliance risk assessment tool.

Future Plans

Recently, the company has collaborated with 2 IT firms, through which it is innovating automation and IT-enabled customized compliance solutions to control and govern DATA life cycle and reduce human interface in data governance life cycle in life science companies. And in the coming days, it will be working on many new projects to bring more innovative solutions.

Words of Wisdom

There is a LOT out there waiting for someone to take it up. India is a large market. Let us help Indian small and medium companies with sustainable solutions so that we avoid foreign currency outgo to large global companies

Potent Leadership

Mahesh Kulkarni

 Founder and CEO

Under the dynamic leadership and excellent direction of Mahesh Kulkarni, QualiCulture Consulting Group is scripting its success story. Mahesh is positioned here as the CEO and controls the overall consulting operations of the company. After spending a 27-year career in the pharmaceutical, biologic and biotechnology industries, Mahesh founded QCG. With his year of industry experience, Mahesh delivers strategic guidance and direction in Quality and GxP Compliance projects. In academic, he did a Master of Science in Microbiology and Post-Graduation Diploma in Quality Management.

Satish Joshi

Partner

Satish Joshi is a Senior Consultant and Partner at QCG.  He has been in the pharmaceutical industry for over 28 years. Satish is basically a Quality Assurance and Quality Control professional experienced in sterile parenteral and solid oral dosage forms. He is a master in business strategy relating to quality assurance, quality control, CMC submissions, laboratory design, and analytical development support. Satish is armed with a Master’s degree in Chemistry and Quality Management.

Neeraj Khare

Senior Consultant

Neeraj Khare is another supporting pillar of QualiCulture Consulting Group and positioned as Senior Associate in the GMP Compliance Practice. He holds 20 years of amazing experience in various dosage forms including sterile and non-sterile. He is perfectly leading the internal and supplier quality, auditing team. He has expertise in interactions with the US FDA, EU, and other worldwide regulatory agencies inspections. In studies, Neeraj did graduation in Pharmacy.

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