We accompany you every step of the way until your product is ready for market.
Clinical Trial Samples
- Packaging / labelling and release and/or complete contract manufacturing of clinical trial samples
- GMP consulting, support or complete takeover of GMP tasks incl. sponsor approval
Solution
picopharma
The direct path for your development project. In line with regulatory guidelines (including ICH Q8), we guide you toward success.
Together with you, we identify key milestones, realistically assess and streamline timelines, and avoid unnecessary detours.
EU-Release
- EU/EEA import: EU market release (EU GMP Annex 21 b) Site of QP certification) and/or the import process (Annex 21 a) Site of Physical Importation)
- GMP-compliant pharmaceutical production at contract manufacturers in Germany and abroad complete supply chain set-up / qualifications / audits
Solution
picopharma
Every hour of delay costs money, time – and potentially your next market opportunity.
In a world where GMP compliance is mandatory, speed becomes a decisive competitive advantage.
picopharma offers:
- Fast, GMP-compliant batch releases
- Tailor-made solutions for pharmaceutical and biotech companies
- Personal contacts instead of queues
We are your reliable partner for GMP import tasks under our DE_BY_MIA_2025_0028 manufacturing authorisation.
Accompanying Consulting
- Development / conversion / expansion of pharmaceutical QM systems
- Support with supply chain qualifications (audits, mock audits, internal audits, inspections by authorities)
- Operational support (e.g. SOPs, qualifications, validations, stability tests, specification creation, process capability analyses, PQR and much more)
Solution
picopharma
Support for your Quality Management System, its extensions, gap analyses and operational ‘hands-on’ support.
We help with customised GMP training workshops, online, in our seminar rooms or at directly at your site.
And: sometimes you just need an extra pair of hands.