Clinical Development
Clinical documents are important for the success in drug development and registration. They are considered key-documents for regulatory Authorities and pave your way throughout development and registration until your product is finally approved and can be marketed. Preparation and review of clinical documents is an activity which requires a high level of proficiency and much experience in the rapidly changing regulatory environment. HORN Pharmaceutical Consulting offers you professional advice throughout all phases of clinical development.
With the right regulatory strategy in mind we will help you to efficiently plan and conduct your clinical studies. We guide you from phase I studies to phase IV studies and support you in bringing new and safe products on the market. We assist you in the preparation and review of the necessary documents (e.g. IMPD, IND, investigator’s brochure, study protocol, informed consent, etc.), and facilitate your way through Authorities and ethics committees. With efficient project management we make sure that you meet your timelines for the start of your clinical trial.
Our in-house and external specialists will provide you with their expert services of medical writing by preparing medically and scientifically accurate, concise and well-structured documents for you. We ensure consistency with the standards of the International Conference on Harmonisation (ICH) and the appropriate regulatory guidelines.
Services
HORN Pharmaceutical Consulting supports your clinical development by offering the following services:
- Provision of strategic advice and development of strategies from concept to commercialization of drug product
- Preparation and review of:
- Investigator's brochures
- Study protocols
- Study reports
- IMPD documents
- CTD documents (e.g. Module 2.5)
- Interaction with study management
- Preparation and organization of meetings with regulatory Authorities
- Efficient preparation of meeting packages (FDA, EMA, national)
- Preparation, review and submission of
- Clinical Trials Applications (CTA) and Investigational New Drugs (INDs)
- Marketing Application Authorisation (MAA) and New Drug Applications (NDA)
- Conduct of GCP audits
- Preparation of potential regulatory agency inspections (GCP)
- Review of proposed product information and drug labelling