Regulatory Compliance Services

zymaxpharma

Regulatory Affairs in the pharmaceutical industry is defined as "The interface between the pharmaceutical company and the regulatory agencies across the world."

Zymax has been providing professional consulting services for the following regulatory region:

USFDA, MHRA, WHO, TGA, MCC, PMDA, CIS, ASEAN, Middle EAST, LATAM, ANVISA, KFDA, EU, PIC/s, GCC, ROW, INDIAN FDA and Emerging Markets.

We undertake the projects on Regulatory compliance services but not limited to:

- Drug Master file (DMF)

- CEP/COS

- ASMF (EU DMF)

- US DMF

- eCTD Compilation

- DMF-Life cycle management

- Technical Packages

- US Agent Appointment

- DMF review (as per ICH guidance)