Qualiculture

About Us

KNOW US
BETTER

Mahesh Kulkarni founded the QualiCulture Consulting Group in 2017 (which in 2021 was transitioned to a Private Ltd entity) to provide consulting services to Pharmaceutical, Biotech, and Medical Device firms.

The purpose was to be a shop floor subject matter expert team and assist small and medium-size companies to establish quality systems in line with regulatory expectations of US and European agencies, considering the product/process lifecycle approach.

Since its inception, the company’s focus has been on assisting firms to establish quality systems, assess the firm’s established procedures, and followed practices to evaluate the compliance at shop-floor level. QualiCulture has performed numerous mock audits to assess the readiness of sites to host regulatory inspections and is involved in inspection readiness activities to obtain regulatory approval and maintain compliance throughout the product life cycle. QualiCulture represents clients to USFDA, MHRA, and Health Canada and has a long-standing history of helping companies to successfully respond to FDA-483 observations, Warning Letters, and Notices of Import Alert and remediate sites to bring the sites back in compliance state in an expeditious manner.

QualiCulture offers sustainable solutions to prevent and resolve compliance problems in the following areas to stay current with the ever-changing regulatory and technical environment, as well as with evolving industry practices.

We Offer :

Inspection Readiness – Mock Audits and SME readiness
Shop – Floor Compliance Verification
Response to Regulatory Inspectional Observations
Remediation for Organizations under Regulatory Enforcement and Outstanding Compliance Issues (Warning Letter and Import Alerts)
Independent Data Integrity (DI) and Product Quality Assessments (PQA)
Aseptic Processing – Microbiology and Sterility Assurance
Review and Assessment of Laboratory Controls and Computerized Systems
Investigators Training and Certification / Investigation of critical discrepancies / non-conformities
Training and Capability Building
Review and Assessment Submitted Regulatory Application (Approved and Pending for Approval) – ANDA / DMF / IND /NDA
Phase Appropriate Quality Management System Design and Deployment