Dealing with questions raised by the regulatory authorities (response documents)
Expert knowledge for your response documents
Our team of pharmacists, physicians, toxicologists, biologists, chemists, food chemists, nutritional scientists, veterinarians and biostatisticians can answer questions relating to all sections of your submission dossier. Their convincing response documents comply with the scientific and formal requirements of all the European regulatory authorities.
A proactive strategy
We see ourselves as an active link between your company and the assessors at the regulatory authorities – and maintain close contacts with both sides. As a result we are in a position to discuss questions with the assessors before your response documents are submitted. This increases the chances of acceptance.
For human and for veterinary medicinal products, our team can assist you in the following areas:
- Regulatory questions
- Quality
- Preclinical issues
- Clinical issues
- Pharmacokinetics
- Pharmacovigilance
