QualiCulture Consulting Group creates a system to balance regulatory requirements, business outcomes and strives to be the most admired consulting partner for Indian healthcare system.
In the past few decades, there has been 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 products, facilities, and systems to Data Integrity hurdles. With the incorporation of more products and 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 manufacturing sites and the gap in understanding the regulatory expectations.
There was indeed a great demand for a proficient expert who could present a complete solution range to the industry. Also, facilitate inculcating the culture of quality and compliance across the industry.
In 2016, QualiCulture made the strategic decision to venture into CGMP and remediation consulting, with the aim of providing valuable assistance to small and medium-sized pharmaceutical companies. This move was driven by the objective of aiding these companies in their growth endeavors by offering expert support without excessive financial burdens.
The company delivers a comprehensive solution for GMP and regulatory compliance to the Pharmaceutical, Biotechnology, Biologics, and Medical Device industry.
Presently, QCG stands out as an industry leader due to its extensive array of subject matter expertise, adeptness in compliance and regulatory strategizing, and strong affiliations with both agencies and industry forums. These factors collectively position QCG as a premier choice, effectively accelerating the compliance journey of its clients.
It offers the best consulting services for addressing the issues of Pharmaceutical, Biotech, and medical device firms.
QCG is focused on providing highly skilled services to clients at an affordable cost. Thus, upbringing the standards of small to medium-sized companies to industry benchmarks and setting new benchmarks for established clients and global players. Here is the list of major services offered by the company:
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 mergers or strategic investments.
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 MNCs operating in India (Team size: 20).
2018: Reached client base of 20, including 5 top Indian MNCs and 5 Global MNCs.
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.
There are 21 major clients consisting of 5 global MNCs and 4 of the top 10 Indian companies. QCG believes in exhibiting a high level of trust in data and information security. It strives to be on a fact-finding mission and not on a fault-finding mission.
The company does its best to highlight problems and provide sustainable solutions to shop floor teams and tries to delight clients every time. To ensure maximum satisfaction, it hires only top-class professionals and technically capable domain experts.
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 within QCG undertake pivotal responsibilities in diverse areas, including facility setup, the establishment of Quality Management Systems, and regulatory filings. They are instrumental in preparing sites for both national and international regulatory agency inspections, effectively managing inspections and addressing observations. Additionally, they play a key role in devising strategies for remediation, facilitating direct interactions with regulatory agencies, and cultivating a lasting culture of quality within the organization.
The company also takes care of each employee and supports 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.
Aside from protocol-based training, ongoing efforts are being made to provide training on regulatory surveillance and related matters. This initiative aims to ensure that employees stay informed about the latest regulations and GMP requirements. Thus, equipping them to meet the updated standards effectively.
Additionally, associates are encouraged to participate in workshops and training conducted by various institutions.
Although the generic pharma business has profitability challenges, BioPharma, biologics, and medical device domain is expanding. It is going to be a growth engine for the companies operating out of India.
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.
In a recent development, the company has entered into partnerships with two IT firms. These collaborations are driving innovation in the realm of automation and tailored compliance solutions that harness IT capabilities. The primary goal is to streamline and oversee the entire data life cycle within life science companies, with the objective of minimizing human interaction. Looking ahead, the company is gearing up to undertake a series of new projects aimed at introducing further groundbreaking solutions.
"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."
(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 academics, he had a Master of Science in Microbiology and a Post-Graduation Diploma in Quality Management.
Satish Joshi is a Senior Consultant and Partner at QCG. He has been in the pharmaceutical industry for over 28 years. Satish is 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 is another supporting pillar of QualiCulture Consulting Group and is positioned as a Senior Associate in the GMP Compliance Practice. He holds 20 years of amazing experience in various dosage forms, including sterile and non-sterile.
Pharmacy graduate Neeraj is leading the internal and supplier quality auditing team. He has expertise in interactions with the US FDA, EU, and other worldwide regulatory agencies inspections.