Development of pharmaceutical products (mainly solid dose formulations) has always been the heart of our activities. ExtractumPharma offers the following services:
• development of generic pharmaceutical formulations
• technenology transfer and analytical method transfers
• activities related to manufacturing site transfer in case of licenced products
Product development
• Preformulation
• Formulation
• Scale-up
• Manufacturing process optimisation and validation
Analytical laboratory
• Analitical method development and validation
• Stablity studies
Regualtory Affairs
We help you navigate the increasingly complex and ever-changing regulatory landscape in order to avoid surprises and meet your key milestones on time and on budget. Our regulatory experts continuously monitor country-specific regulatory and ethics restrictions and requirements and liaise with all relevant stakeholders so that submissions are always fully compliant.
Connecting to our pharmaceutical development and licencing in-out services our RA include:
1. Evaluation of existing documentation with regard to the requirements of the given target country
2. Compilation of a complete or partial registration documentation
3. Management of the registration procedures at the local authority
4. Renewal, maintenance, harmonisation of the registration documentation
5. Administration of marketing authorization
