We provide practical knowledge and experience on implementing Quality Management System (QMS) to meet cGMP requirements based on international regulations.

We use our experience based on successful past projects that gives us an edge to bring down turn around time.

Standardized Policies, Standard Operating Procedures (SOPs), Protocols and Documents available in our data bank can be optimally utilized.

We liaise with our clients to identify loopholes in the ‘Quality System’.

We help to resolve ‘Data Integrity’ related challenges pertinent to laboratory and production controls. We offer to establish robust ‘Data Governance System’ to eliminate potential data integrity risk.

We perform GLP, GMP gap audits / assessments, specific investigations and provide remediation plans to bridge those gaps. Confidentiality of information is guaranteed.

We understand ever changing dynamics of regulatory environment. We collaborate with our business partners for Compliance of facility and system as per US, Europe and other Regulatory requirements.

We actively engage with our clients to prepare for customer / regulatory inspections such as US FDA / EU / TGA / MHRA.

We offer to write compliance response to the regulatory agency on behalf of our clients.

We support to establish ‘Quality Risk Management’ System to mitigate quality, regulatory and business risks.

We help our clients to identify and control potential quality issues from development stage to manufacturing stages to ensure the high quality of the drug (medicinal) products to the patient.

We want our clients to conserve valued resources such as man hours and time. We provide end to end services that captures entire life cycle of ‘Vendor Management Program’.

We have certified auditors (American Society for Quality Certified Quality Auditor, APIC Certified Auditor, Global Exemplar Certified QMS Auditor) with extensive experience of conducting more than 500 vendor / contractor audits across Globe.

We assure to free up valuable quality resources of our clients and thus facilitate to focus on strategic supply relationships.

We want our clients to benefit from our knowledge and experience. Quality training at a grass root level is a need of a time.

We provide comprehensive awareness and competency ‘Trainings’ on various GXP topics.

We conduct on site training sessions to save time and accommodate maximum employees.

We offer training material, assessment and participation certificates.