Regulatory affairs

Strict regulatory compliance is not only a service we offer; rather, it is a truly essential pillar to every single project we lead. Identifying, mitigating and eliminating risks at all stages is crucial to enhance trust among our customers.

Discover how we can support you in terms of regulatory compliance, including our full-fledged contract research and audit management services.

360° platform

Evaluation of capabilities and focus on quality to help customers meet the highest quality standards of their product
Ability to act independently
Quality-driven approach that creates significant efficiencies reducing time and error
Interfacing between manufacturers and customers
Implementing quality management systems at all levels as per ISO 9001:2015, we bring in a 360° universal approach to our services

Principal responsibilities

Monitoring and measurement of products 
Maintaining and streamlining expansive databank of document management such as product specifications, safety data sheets and product literature
Assisting customers for plant approvals through GMP & neutral GMP audits
Management of the vendor evaluation process
Independent laboratory evaluation and product analysis
Customer assistance in fulfilling REACH requirements
Managing business secrecy through diverse agreements 
Management of quality complaints
Seamless communication with customers

Contract research services

Our spectrum of services includes analytical management at early stages of drug chemistry, from laboratory scale to full-scale commercial production.

Our efficiencies can be intelligently combined to open unique opportunities and respond to complex problems or specific needs of our customers through a full-time equivalent [FTE] model or stand-alone project management.

Audit management services

We conduct paper audits, as well as facilitate site audits and inspections for APIs, intermediate plants or any other product including industrial chemicals and food and feed raw materials.