Developing a new medicinal product (MP) is a lengthy process. A comprehensive plan and the right regulatory expertise can significantly accelerate the development timeline.
Stage 1: Scheduling
Develop a product development plan and regulatory strategy. Adjustments can be made at each phase of the development as needed. Don’t forget to plan the manufacturing of your MP during all stages.
Stage 2: Preclinical Development
Evaluate the MP and conduct preclinical studies, like safety, pharmacodynamics, toxicology and pharmacokinetic studies. At the end of the preclinical development phase the clinical trial should be designed, and a clinical trial application should be submitted to regulatory authorities.
Stage 3: Clinical Development
Clinical development includes safety monitoring in healthy volunteers (phase 1), safety and efficacy monitoring in a larger cohort of patients (phase 2) and assessment whether the MP is safe and effective in an even larger cohort of patients (phase 3). At the end of the clinical development, a marketing application should be prepared and submitted to regulatory authorities.
Stage 4: Post-Market Safety Monitoring / Life cycle management
Once your marketing application is approved, post-marketing safety monitoring is required. Also, your marketing application needs to be kept up to date with all relevant changes.
At StaroDub BV, we can support your product development at all stages in a timely and efficient manner.