- Advice on strategic development
- Monitoring of preclinical studies
- Preclinical study reports
- Preclinical dossiers
- Expert reports
- Environmental risk assessment (ERA) reports
- Drug substance analyses and drug product development
- Literature searches relating to preclinical issues
- Regulatory consulting and guidance at regulatory submission
- Cooperation with external specialists
1. Advice on strategic development
This service targets the design of single studies as well as the development of complete preclinical programmes. Objective, design and data analysis strategies of studies are challenged and optimised in accordance with regulatory requirements.
2. Monitoring of preclinical studies
Critical review of study protocols and monitoring of studies placed at CROs are indispensable for achieving a valid outcome of experimental studies. We evaluate and accompany preclinical investigations critically and independently.
3. Preclinical study reports
Writing and reviewing of preclinical reports is often a rate-limiting step for pharmaceutical companies. Outsourcing to Pharma Consulting Aachen allows efficient and impartial processing of this task in one hand. Our services cover preparation and evaluation of pharmacological, toxicological, and pharmacokinetic expert reports, as well as documents on pharmaceutical quality.
4. Preclinical dossiers
Acquisition of investors as well as in- or out-licensing of drugs in early development requires thorough and competent review of the data. This is all the more true if dossiers are prepared for submission at regulatory agencies. We review the data for completeness, technical competence and scientific content. Dossiers are assembled i.e. for investigator’s brochures, CTDs or IMPDs in a critical and independent manner.
5. Expert reports
We provide and evaluate independent expert reports to clarify factual situations in legal conflicts. These can involve pharmacological, toxicological, pharmacokinetic, and biochemical-pharmacological issues.
6. Environmental risk assessment (ERA) reports
A guideline on the environmental risk assessment of medical products for human use has been implemented since December 2006. Pharma Consulting Aachen supports companies dealing with this requirement by reviewing study designs, analysing data and writing the corresponding reports.
7. Drug substance analyses and drug product development
Pharma Consulting Aachen offers expertise in drug product development according to up to date standards of process analytical technology (PAT), design of experiment (DOE) and quality by design (QbD) including the performance and evaluation of chemometric and multivariate data analyses.
8. Literature searches relating to preclinical issues
We offer literature searches for specific preclinical problems. Searches are conducted in databases accessible via internet and publications (abstracts and/or full papers) are delivered electronically or as hardcopy.
9. Regulatory consulting and guidance at regulatory submission
Personal work experience and insight into the German regulatory agency BfArM facilitate approach to and cooperation with the authorities. This can help especially small pharmaceutical companies with limited expertise with regulatory authorities. We have experiences with the regulatory authorities of the USA and aid successful completion of national, European and international admission procedures. Furthermore, we support companies dealing with complicated regulatory challenges.
10. Cooperation with external specialists
Drug development is a complex and multi-disciplinary challenge. In case that questions will arise not covered by our expertise, Pharma Consulting Aachen is supported by a network of independent specialists covering each topic.
