Drug Substances

Drug Substances von HORN Pharmaceutical Consulting

Von: HORN Pharmaceutical Consulting  08.07.2009
Keywords: Projektmanagement, Consulting, Training

 HORN Pharmaceutical Consulting can not only help you to adjust to the global demands, but with our comprehensive API services you will be able to stay ahead in this rapidly growing industry.

With us you will maximize your success in drug substance development. Our specialists will help you to understand the important characteristics of your Active Pharmaceutical Ingredient (API), its control in manufacturing and release as well as its consistent production. We have solid in-depth knowledge of the EMEA and FDA regulations and ICH guidelines which will hep you determine the specifications for Active Pharmaceutical Ingredients (APIs), raw materials, intermediates, drug products and excipients to ensure that they comply with the respective Pharmacopoeias and regulatory requirements.

We are offering the following services in the API area: 
Regulatory filings in Europe and US, ranging from IMPD/IND to MAA/NDA-submissions
Preparation and submission of:
     Drug substance part of the CTD
     Certificate of suitability (CEP)
     European Drug Master File (ASMF) 
     US Drug Master File (DMF)
Preparing GMP systems for APIs for clinical use and for commercial production
General analytical testing
Analytical validation
Process validation
Method development
Stability testing programs
Regulatory affairs
Quality assurance

Keywords: Active Substance Master File (ASMF), advanced therapy industry, API (Active Pharmaceutical Ingredient) manufacturer, Biotech products, Certificate of suitability (CEP), Clinical Development, Consulting, CTA (Clinical Trial Application), Horn, IMPD, IND (Investigational New Drug Application), MAA (Marketing Authorisation Application), medical device industry, NDA (New Drug Application)/ BLA (Biologic License Application), New chemical entities, Non-clinical Development, Projektmanagement, quality systems, Regulatory Affairs, Regulatory Authorities, SOPs, Training,

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