Biotechnological Products

Biotechnological Products von HORN Pharmaceutical Consulting

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

 With the increasingly global nature of the biopharmaceutical industry, it is becoming more and more difficult to have a competitive advantage. In order to decrease time, cost and risk related to the development and launch of new biotech products, you need a reliable partner to help you cope with the constantly changing regulations. HORN Pharmaceutical Consulting can be your experience guide through the regulatory jungle.

Your Benefits:
·         Experienced and reliable partner
·         Adequate capacities for all of your needs
·         One service for all your demands
·         Well established communication procedure
·         High success rate
·         Confidentiality and adherence to professional standards of excellence  

Our Experts
Our experts are specialized in various kinds of biotechnological products ranging from antibodies and proteins to vaccines, etc. They will establish and control your biotechnological product development or regulatory strategy, with a plan that meets your product’s milestones.   Dr. Hiltrud Horn, the founder of HORN Pharmaceutical Consulting, has more than 19 years of experience in the pharmaceutical and biotechnology industry. She is regularly invited speaker at conferences, workshops and seminars on the development and registration of new chemical entities and biotechnological products.  

Global Expertise
Our experts will help you provide a satisfactory response package to the respective Authorities as we are global actors. We can prepare validation master plans that are comprehensive and in full compliance with all regulatory requirements (US, EU and national). Furthermore, we have extensive experience in the establishment of documentation standards and in the validation of biopharmaceutical facilities, equipment, and processes.  

We have the experience, creativity, ideas and power to support you with the following services:

Regulatory Affairs:
·         Advice on requirements and design for clinical trials in Europe and US
·         Review of protocols and reports
·         Preparation and compilation of clinical trial applications (CTA, IND)
·         Preparation and compilation of marketing authorisation applications (CTD)
·         GMP / GLP / GCP compliance  

Chemistry, Manufacturing and Controls:
·         Creation of CMC standards for biopharmaceutical development programs
·         Manufacturing and control requirements
·         Review of production processes and facilities
·         Criteria for product characterisation
·         Advice on specifications
·         Requirements for raw materials
·         Requirements of product controls
·         Design of validation protocols and review of validation reports
·         Planning of appropriate stability studies  

Project Management
·         Development of regulatory strategies
·         Advice on manufacturing strategies
·         Design of development programs encompassing non-clinical studies and clinical trials
·         Preparation of project status reports
·         Coordination between contract manufacturers and control laboratories
·         Analysis of resource requirements
·         Planning and control of projects
 ·         Analysis of time-lines and costs  

Interaction with Authorities
·         Preparation and conduct of meetings with Authorities from clinical trial applications, orphan designation, marketing authorisation application, variations and renewals in Europe and the US
          o        Efficient preparation of meeting packages (national, EMEA, FDA) 
          o        Specific training
          o        Participation in meetings
          o        Follow-up activities
·         Technical writing, in the field of biopharmaceutical products
·         Responses to agency questions and objections

Keywords: Active Substance Master File (ASMF), advanced therapy industry, API (Active Pharmaceutical Ingredient) manufacturer, Biotech products, Certificate of suitability (CEP), Clinical Development, Consulting, contract laboratory, CTA (Clinical Trial Application), Due Diligence, 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, Regulatory Intelligence, SME (Small and Medium-sized Enterprise), SOPs, Training,

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