Atlas Global Consulting, Inc. Strategic Solutions for Growth
Expert guidance in Regulatory Affairs Management and Strategy.
Regulatory Affairs Services to Maximize Business Success
Pre-IND Strategy
Our team of experts will help you develop a clear and concise Pre-IND strategic plan that aligns with your business and investor goals and objectives.
IND Compilation and Filing
We offer eCTD IND submission compilation for filing an acceptable IND for your coveted "Study May Proceed" Letter.
Pre-NDA or BLA Meeting Strategy
Our experts will help you develop and implement an effective Pre-NDA/BLA Meeting strategy to consider any cost-saving waivers or exemptions and key deliverables required for NDA/BLA Filing.
NDA, BLA or ANDA Submission Compilation and Filing
We provide customized eCTD Outlines and manage DMF and CMO coordination that will help you streamline time to submission and improve your approval probability.
Warning Letter & Complete Response Letter Responses
Our consulting services will help you review Warning Letter strategies and use FDA legal precedence, to help restore cGMP Compliance. For CRL Response we 'speak FDA' and can interpret best responses to help move from CRL to Approval.
US Agent Services
We offer comprehensive US Agent services to set up FDA Accounts thru CDERDirect to help your pharma company to obtain pre-assigned application numbers, NDC Labeler Codes and register products. We also offer assistance in navigating FDA Import/Export Customs issues ensuring the long-term success of your business.