Pharmaceutical operations

Pharma Dossier Preparation

Compliance assessment of the regulatory dossier submitted

Due diligence of sites

Cleaning Validation

Aseptic Process Validation

GMP, GLP and GCP for clinical trial centers

Regulatory aspects of Pharma operations - USFDA, MHRA, TGA, HSA, Anvisa Brazil

Pharma Formulations - Development to Scale up

Importance of Biosimilars

Biotechnology and Biopharmaceuticals

OTC products manufacture and Regulatory aspects for Dossier Filing in SEA

Basic Principles in Design of Oncology facilities

Stability Programs in Biopharmaceuticals

ANDA, NDA, BLA filings

Cold Chain Management.

Support for OTC product development ( antiobess drugs)

Regulatory approvals at local Drug control Bangalore and DCGI Delhi

Site Monitoring and KPI management.

*Structured Workshops in Association with an outside Partner

** Collaboration with experts having long experience of Pharma Industry.

*** Services from experts on IPR and Investigation.