Biotechnological Products
Today's biotechnology knows no boundaries. The success obtained by genome sequencing efforts over the past year have provided the biotechnology sector with fresh opportunities to meet newly adjusted goals for supporting the pharmaceutical industry. However, development and commercialization of new biopharmaceutical product and technology is a challenging task. No matter whether your product is in the pre - clinical, clinical or marketing phase, HORN Pharmaceutical Consulting can help you cope with the regulatory jungle.
The regulatory authorities require suitable analytical methods to assess purity and stability of product development. Our experienced consultants can help to establish your biotech product development or regulatory strategy, with a plan that meets your product’s milestones.
Our Experts
Dr. Hiltrud Horn, the founder of HORN Pharmaceutical Consulting, has more than 30 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 biotech products. We have experts specialized in various kinds of drug substances and formulations ranging from small molecules, peptides, to biological and biotechnological products (e.g. antibodies, proteins, vaccines, etc). We furthermore support you with experience and know-how in the area of advanced therapies, such as biotissues and somatic cell therapies.
Global Expertise
The regulatory procedures for biotechnological products in Europe and US are significantly different. Our specialists will help you provide a satisfactory response package to the respective Authorities. We can prepare validation master plans that are comprehensive and in full compliance with all regulatory requirements (US, EU and national). We assist clients in the establishment of documentation standards that are practical and compliant. Furthermore, we have extensive experience in the validation of biopharmaceutical facilities, equipment, and processes.
Services
Our services include:
- 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,
- Design of development programs encompassing non-clinical studies and clinical trials
- Review of protocols and reports
- Design of clinical trials
- Advice on requirements for clinical trials in Europe and US
- Preparation and compilation of clinical trial applications (CTA, IND)
- Analysis of time-lines and costs
- GMP / GLP / GCP compliance
Project Management
- Development of regulatory strategies
- Advice on manufacturing strategies
- Preparation of project status reports
- Coordination between contract manufacturers and control laboratories
- Analysis of resource requirements
- Planning and control of projects
Interaction with Authorities
- Preparation and conduct of meetings with Authorities from clinical trial applications, orphan designation, marketing authorisation application, variations and renewals
- In Europe: scientific advice meeting, protocol assistance meeting, pre-submission meeting
- In US: pre-IND-meeting, end of phase II meeting, pre-submission meeting, advisory committee meeting, scientific meetings
- Efficient preparation of meeting packages (national, EMA, FDA)
- Technical writing, in the field of biopharmaceutical products
- Responses to agency questions and objections