Lack of in-house expertise and documents prepared by inexperienced sources can cause insufficient or inefficient regulatory documents and submission dossiers or query responses. Insufficient or inefficient documents can result in rejection of applications, multiple queries, delay in regulatory review, changing in–house or external facilitators – this could lead to long turnover time and perhaps additional costs. For urgent needs, guidance, and unresolved issues you could contact an experienced partner to assist you. Our regulatory consulting focusus on:
Non Clinical Review, Strategy & Compilation
Clinical Review, Strategy & Compilation
Update or Defend Product Labeling Texts
Biopharmaceutics Review, Strategy & Compilation
Pharmacology Review, Strategy & Compilation
Microbiology Review, Strategy & Compilation
Clinical Pharmacology Review
Bioequivalaence Review, Strategy & Compilation
Administrative Document Review, Strategy & Compilation
Health Authority Query Response
Pharmacovigilance Compliance Support
Health Authority Compliance (GCP, GLP, GMP, GDP, QMS) Implementation
