Pharmaceuticals

PHarmaceuticals - Human & Veterinary

Complying with the worldwide rules and regulation set forth by various organizations and governing bodies is a daunting task for any pharmaceutical business. It requires patience, persistence and experience to keep things moving forward.

Whether you're bringing an new drug to market or going global with an existing drug, this activity presents a series of regulatory challenges, that must be resolved quickly, to avoid delay in getting your product to patients.

We offer the following services in the area of pharmaceuticals

Clinical Product Development

Clinical Strategy Development
Clinical Trial Dossiers
Product Development Pathway
Development of clinical and non-clinical trial protocols
Medical Writing/CSRs

Global Regulatory Affairs Support

Training on global pharmaceutical regulatory compliance
Authorized representative/Agent in the United States, Canada, European Union, Latin America, Asia-Pacific, MENA, South Africa
Global Regulatory Intelligence for licensing, registrations, renewals, variations, labeling, and on-going updates
Pharmacovigilance/ADE reporting and Support Call-in center

International Regulatory Documentation Submissions

New Drug Application (NDA)
Ex-US Registration
Common Technical Documents, CTD formatting and submission
Variations & Amendment filings
Pharmaceutical license renewals
Special Access: Orphan Drugs, Compassionate Use, Named Patient

Quality Assurance, Auditing & Inspections

Pharmaceutical mock audits
Assistance with GMP, GCP/GLP inspections
Risk Management Auditing
Evaluation of quality systems and processes
Manufacturing related quality support: Process validation, cleaning validation, equipment validation, and technology transfer