Compliance Audit & Risk Management
We offer services covering the complete cGMP value chain for all compliance needs. With the procedural know-how for manufacturing all standard dosage forms, we assist in creating or redesigning processes and procedures as per regulatory specifications and best industry practices. When you place your trust in our experience, you will derive benefits from a high level of certainty and expertise. We believe that the best solution is often the one that is simple, smart and fundamental.
Gap analysis and remediation
We use risk and vulnerability assessments for a thorough gap analysis in comparison to applicable regulations. We work with you to identify potential vulnerabilities and ensure that nothing is left to chance with our detailed remediation plans. You can rely on us to ensure that all discrepancies have been identified and reconciled at strategic and operational levels.
cGMP compliance
You can gain full access to our deep knowledge of compliance with extensive consultation. We offer tailor-made solutions for cGMP gap analysis and compliance for sterile and non-sterile facilities for both human and veterinarian products.
cGMP Audits
We offer expert insights on WHO, FDA, MHRA, EU, and ISO compliance. We are skilled at handling customer audits and audits by regulatory agencies like the US FDA (CBER BIOLOGICS), MHRA, CDSCO/FDA (India), ISO etc. We craft customized solutions post-audit, with transparency, to support our clients with problem-solving and change management.
Quality Risk Management (QRM)
We have learned that systematic risk management is the bedrock of quality. We design and implement a customizable QRM framework for improved decision-making and assurance to regulatory agencies and clients. We assist in designing effective, efficient and economical solutions to maintain quality throughout the product lifecycle.