Our Services include, but are not limited to:

• Regulatory strategy for global drug development
• Common Technical Document (Modules 1 through 5)
• Variations, Amendments and Supplements to Applications
• Clinical trial Applications (IND/IMPD/CTA)
• Drug Master Files and Site Master Files
• Electronic Submission for Drug Establishment Registration and Drug Product Listing
• Summary Product of Characteristics and Target Product Profile
• Regulatory writing for submission (CMC, preclinical and clinical overview and summaries)
• Liaison with Regulatory Authorities
• Training in-house customized
• US Agent for non-US Pharmaceutical companies
• GMP, GLP and GCP audit
• Audit for US Pre-Approval Inspection
• Responses to deficiency letters
• Quality Systems