Biotechnology
  • RegSource senior consultants can help you develop the right candidate product from proof of concept to approval. From assisting in developing your Recombinant Vaccines, Growth Factors, MAbs, Therapeutic and Prophylactic Vaccines, new products, new delivery systems and Biosimilars. The services we provide to the Biotechnology industry includes, Regulatory Strategy, Regulatory Operations, Clinical, Nonclinical , CMC, Compliance and Regulatory Project/Program Management consulting. These services include:
  • Selecting the right proof of concept candidate
  • Gap Assessment of your current Nonclinical/Clinical/Manufacturing/
    Regulatory Processes
  • Regulatory Agency Meetings
  • Product Development Strategy
 
  1. Developing Target Product Profiles
  2. Developing Clinical Development Plans
  3. Nonclinical Development Strategies
  • Lifecycle Management Planning
  • Developing regulatory pathways for accelerated approvals
  • Developing cost effective and efficient development strategies
  • Ensuring compliance and effective Quality Systems
  • Effective Program Management to accelerate product approval timelines
  • Preparation and review of all CMC sections for regulatory submission
  • Response to Regulatory Agency deficiency letters
  • Assistance in validation activities
  • Creation of GMP SOP’s
  • Creation of Quality Manuals
  • Creation of QA/QC SOP’s
  • Pharmacovigilance Strategies
  • Clinical Trial Design and Trial implementation Planning
  • Review of Clinical Sections of submissions
  • Provide ongoing regulatory oversight of clinical trials
  • Preparation of Pharmacology and Toxicology sections for regulatory submissions
  • Pharmacology and Toxicology program review and development
  • Development of Product Development Plans
  • Development of Target Product Profiles
  • Development of Clinical Development Plans
  • Regulatory Program/Product Management
  • Regulatory Agency Inspection Preparation
 
  • Whether you are searching for advice on setting up a clinical site to submitting a Biological Investigational Drug Application or Biological New Drug Application, creating new manufacturing suites or addressing post-marketing requirements, we can help you achieve your goals within your timeline.
  • 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.
  • Contact us and find out how RegSource Consulting can help.