Our in-house auditing team, supported by local members, assists in all aspects of auditing by providing the following services:

• GMP Pre-Audits and GMP audits for Drug Substances and Drug Products (API and FDF)
• Identification of Gaps
• Guiding and Working through with the CAPA’s
• PIC/s GMP certification application submission and liaison with Country specific authority
• GMP training
• Workshops on QMS and Technical writing

One of our key differentiators is the cadre of scientific and technical experts. With decades of experience in the industry of different magnitudes and sizes, our consultants have the real-world knowledge and experience required to deliver accurate and actionable recommendations.

We provide technical consultancy services in the following areas:

• Quality Culture and capability building programs
• Operational Excellence

Regulatory submissions for PICs/GMP certification applications, liaison with country specific authority and query responses.