Pharmaceuticals
  • The Pharmaceutical industry is a knowledge based business, and that means one of its most important resources is skilled, knowledgeable people. Our team at RegSource Consulting is dedicated to providing you the skilled people you require to support all of your regulatory needs. The services we provide to the Pharmaceutical industry include Regulatory Strategy, Regulatory Operations, Clinical, Nonclinical and CMC, Compliance and Regulatory Project/Program Management. These services include:

  • Strategy for Agency Meetings
  • GLP/GCP/GMP implementation strategies
  • Developing Target Product Profiles
  • Developing Clinical Development Plans
  • Nonclinical Development Strategies
  • Chemistry and Manufacturing Strategies
  • Responses to Agency Questions
  • Submission Management
  • Electronic Submission Publishing and Management
  • Regulatory Operations
  • Clinical Trial Design and Trial implementation Planning
  • Review of Clinical Sections of submissions
  • Provide ongoing regulatory oversight of clinical trials
  • Provide support in submission of regulatory documentation required for national and international Ethic Committees/IRB
  • Preparation of Pharmacology and Toxicology sections for regulatory submissions
  • Pharmacology and Toxicology program review and development
  • Gap Assessment of current Nonclinical programs
  • Gap Analysis of all current CMC processes
  • Preparation and review of all CMC sections for regulatory submission
  • Assistance in validation activities
  • Advertising and Promotional Compliance
  • Labeling and Packaging Compliance
  • Regulatory Agency Inspection Preparation
  • GLP/GCP/GMP Audits
  • Regulatory Program Product Management
  • Regulatory Product Project Management
 
  • Managing current federal and state regulations to ensure your pharmaceutical product is compliant with existing agency requirements within your Clinical, Manufacturing, Nonclinical (Pre-Clinical), Regulatory and Commercial departments is a critical, complex and challenging process.
  • Our experienced team strives to understand your current corporate timelines and challenges within your organization, and then subsequently matches your requirements with the skilled personnel necessary to achieve your product development goals.
  • We have access to experienced senior consultants with experience in developing products from proof of concept to commercialization and post marketing.

Contact us and find out how RegSource Consulting can help you find the ideal consultant today.