Intermediates for Pharma
Midas Pharma is providing products and product related services in the fields of intermediates and Starting Materials for APIs (Active Pharmaceutical Ingredients). A global network and many years of experience enabled us to build up resilient supply chains which are in compliance with contemporary quality and environmental standards. Our products are supported by state-of-the-art regulatory documentation customized to your needs thus enabling a smooth approval by health authorities.
Working with Midas Pharma means:
- More than 30 years of experience and networking in the pharma industry
- Full coverage of regulatory aspects
- Full QM (Quality Management) support
- Securing, upgrading & derisking critical supply chains
- CLP (Classification, Labeling & Packaging) & REACh (Registration, Evaluation, Authorisation and Restriction of Chemicals) compliance
- Import & transportation of dangerous goods
- Warehousing
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Strategy for defending and justifying complex starting materials towards Health Authorities
- Impurities (M7, Q3A, nitrosamines) carry-over and risk-assessment
- CMC documents compilation
- Regulatory/QM support during filing/ Lifecycle Management
- Fall-back plan
Intermediates with ICH Q11 compliant documents -
- Internal database with over 10k starting materials and intermediates entries
- Technology database supporting the identification of the right CDMO for your product
Is your process still state of the art and/or competitive? We are experienced in offering a customized solution.
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Challenges of old supply chains:
- Documents & processes are no longer state of the art
- Importance and interest of the concerned substance may change to the supplier
- Changes always trigger immense internal capacities
Advantages of an up-to-date/improved supply chain:
- De-risking shortage risks
- Availability of upgraded documentation → possible extention to other markets & products
We offer you a full-service package including technical, regulatory affairs and qualification support customized to your requirements sharing the load of your internal work.
Overview Intermediates for Pharma
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Your Contact
Dr. Danielle Leone-Stumpf
International Division
Senior Director Intermediates for Pharma & Biopharma
Rheinstr. 49
55218 Ingelheim
Germany