Company Profile
COMPANY
PROFILE
Qualiculture Bio-Pharm Services Private Limited, a firm specialized in providing comprehensive cGMP consultancy services for pharmaceutical, Biotechnology and medical Device industry. A team of industry veterans who have worked in few of the top 10 pharma companies in India and abroad, founded the QualiCulture Bio-Pharma Services in 2021 to provide the consulting services for supporting small and medium size Pharmaceutical, Biotech and Medical Device firms in India and Asia for managing complete life cycle activities.
QualiCulture offers sustainable solutions at reasonable cost to prevent and resolve compliance problems in following areas and to stay current with the ever-changing regulatory and technical environment.
New facility design, commissioning and qualificationLegacy facilities assessments for operating feasibility and modificationsNew facility design, commissioning and qualificationAutomation solutions in manufacturing, Engineering and quality control and 21 CFR part 11 and GAMP assessmentsSetting up QMS basis current regulatory expectations including senior management governance mechanismInspection Readiness – Mock Audits, SME readinessShop – Floor Compliance VerificationResponse to Regulatory Inspectional ObservationsHand holding during Remediation for Organizations under Regulatory Enforcement and Outstanding Compliance IssuesAutomation solutions in manufacturing, Engineering and quality control and 21 CFR part 11 and GAMP assessmentsReview and Assessment of Laboratory Controls to ensure data integrityReview and Assessment Submitted Regulatory Application (Approved and Pending for Approval) – ANDA / DMF / IND /NDA for ensuring data integrity and adequacy.The QualiCulture team consists of over 50 consultants. The consultants consist of Industry Experts, who were individually selected based on experience and area of expertise. Our pharmaceutical consultants have experience ranging from Product Development (Manufacturing and Analytical), Manufacturing (Active Pharmaceutical Ingredients, Non-Sterile Dosages, Sterile Dosages, Biologics, Vaccines and Medical Devices), Quality Control, Microbiology and Computerized Systems. Our team is uniquely qualified to assess your company’s facility, and provide specific direction to achieve the successful inspection outcome. We not only identify potential areas of concern, but also provide specific advice on how to remediate.
Where can we assist our clients?
Lifecycle Based Support for Every Need
QualiCulture provides the life cycle-based support for all the ‘Pharmaceutical, Biologics, Vaccines and Medical Device’ companies based on their regulatory compliance needs.