From reviewing draft development plans, stability and development reports, through to full plan development from candidate selection through to commercialisation and marketing, including interactions with international regulatory agencies, PJC Pharma Consulting Ltd can assist your business. Expert report writing for product assessments and submission reviews can all be offered depending upon your exact requirements.
•devise formulation plans with recommended experiments & excipients defined
•provide development rationales
•take existing compounds and advise on repurposing
•provide guidance on regulatory trouble-shooting in response to regulatory agency questions
We can assist you in devising a comprehensive and acceptable path forward for your small molecule and biologic assets.
Please contact us to discuss your specific requirements.