Catalyst Pharma Consultancy

Comprehensive cGMP consulting services provider for Drug substances, Intermediates, Drug Products, Excipients, packaging materials & Related industries. Third-party vendor Audits. End-to-End solutions – Gap Assessment & Solution Provider Data Reliability Assessment Hand-Holding for Inspection Readiness Customized Training & Mentoring Programs Partnered with Consulting firms of International repute to get need-based Support( We are partener with Ex-USFDA and EX-MHRA Inspectorates.) Evaluating written procedures and standard operating procedures Developing laboratory quality, analytical methods, methods validations, and product component specifications Creating a program to meet current FDA expectations for GMP/GCP/GLP Compliances.Inspection readiness. Audit preparedness. Product, systems, and facility validation and qualification Our team of FDA experts understands the importance of a successful inspection and the role that a solid audit can play in your inspection outcome. Whether the objective is compliance with GMP, GCP or GLP, our tailored audit services help you minimize inspection risks, allowing you to focus on the big picture for your business. Evaluation of products, equipment, and facilities Qualification of policies, procedures, protocols, and master plans Computer systems and 21 CFR Part 11 Compliance Validation of: - Products, equipment, and facilities - Manufacturing, packaging, and labeling processes - Cleaning and sterilization systems and processes.