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

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

QualicultureConsulting Group: serving the community by advancing translucent qualityculture in healthcare

QualiCultureConsulting Group creates a system to balance regulatory requirements andbusiness outcomes and strive to be most admired consulting partners for IndianHealthcare System.

In the past few decades, there is hugegrowth in the Indian Pharmaceutical Industry, but there are numerous challengesas well. As the industry has expanded to commendable heights, with an increasein the product portfolio, volume, and global presence, the complexities havealso increased, affecting the quality of the product.

The issues faced by the industry variedfrom the performance of product, facility, systems to Data Integrity hurdles.With the incorporation of more products, an increase in volumes, procedureswere not simplified in line with exact practice or exact requirements, oftenleading to errors in execution. The deployment of automation through IT systemshas created the transparent backend data archival which added to thecomplexity.

Additionally, in this phase, the countrywas witnessing a high level of regulatory challenges in terms of GMP complianceat manufacturing sites and the gap in understanding of the regulatoryexpectations. There was indeed a great demand for a proficient expert who canpresent a complete solution range to the industry and facilitate in inculcatingthe culture of quality and compliance across the industry.

In 2016, QualiCulture decided to enter incGMP and remediation consulting, to cater to small and medium-size Pharmacompanies and support them in expanding their business with reasonable spend onexpert support. The company delivers a comprehensive solution for GMP andregulatory compliance to Pharmaceutical, Biotechnology, Biologics, and MedicalDevice industry. Today, the wide range of subject matter expertise, complianceand regulatory strategizing skills and association with agencies as well asindustry forums, makes QCG the best in the industry thereby to act as acatalyst in compliance journey of clients. It is offering the best consultingservices for addressing the issues of Pharmaceutical, Biotech, and MedicalDevice firms.

Services underthe Hat of QCG

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

Pharma BiotechServices

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

The Journey fromInception to Present-day

2016: Initiation of QCG (team size 3)

2016: Received first 5 clients includinga large company in India

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

2018: Reached client base of 20 including5 top Indian MNC and 5 Global MNC

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

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

Clientele

There are 21 major clients consisting of5 global MNC and 4 of the top 10 Indian companies.  QCG believes in exhibiting a high level oftrust in data and information security and strive to be on a fact-findingmission and not on fault-finding mission.

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

Team and WorkCulture

Qualiculture Consulting Group is a bunchof 40 experienced professionals who are dedicated and passionate about theirwork and perform in all ways to assist clients. Partners and senior consultants at QCG play crucial roles in facilityset up, establishing Quality Management Systems, regulatory filings; preparingthe 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 asustainable culture of quality in the organization.

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

Significance ofthe Advanced Technologies and Tools

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

Milestones andAchievements

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

Future Plans

Recently, the company has collaboratedwith 2 IT firms, through which it is innovating automation and IT-enabledcustomized compliance solutions to control and govern DATA life cycle andreduce 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 moreinnovative solutions.

Words of Wisdom

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

Potent Leadership

Mahesh Kulkarni

 Founder and CEO

Under the dynamic leadership andexcellent direction of Mahesh Kulkarni, QualiCulture Consulting Group isscripting its success story. Mahesh is positioned here as the CEO and controlsthe overall consulting operations of the company. After spending a 27-yearcareer in the pharmaceutical, biologic and biotechnology industries, Maheshfounded QCG. With his year of industry experience, Mahesh delivers strategicguidance and direction in Quality and GxP Compliance projects. In academic, hedid a Master of Science in Microbiology and Post-Graduation Diploma in QualityManagement.

Satish Joshi

Partner

Satish Joshi is a Senior Consultant andPartner at QCG.  He has been in thepharmaceutical industry for over 28 years. Satish is basically a QualityAssurance and Quality Control professional experienced in sterile parenteraland solid oral dosage forms. He is a master in business strategy relating toquality assurance, quality control, CMC submissions, laboratory design, andanalytical development support. Satish is armed with a Master's degree inChemistry and Quality Management.

Neeraj Khare

Senior Consultant

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

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