The CCDRD AG regulatory network team understands the complexities and time associated with obtaining a product registration. Our skilled regulatory team works with you to prepare and complete global or local submissions and liaise with regulatory agencies to facilitate successful authorization.
We provide you with support around the following regulatory issues: - Global regulatory strategies
- MAA / NDA / BLA / NDS - Chemistry & Pharmaceutical documentation
- Pre-clinical documentation
- Clinical (including ISS/ISE) documentation
- Expert reports and summaries
- Human and veterinary products
- Submission through to authorization
- European centralized and mutual recognition procedures.
- Regulatory consultancy; position papers, developmental problems, regulatory issues
- Investigational drug brochures / clinical trial applications (CTX/IND), clinical study reports / manuscripts / PSUR
- GCP/GLP/GMP compliance BSEN ISO9001 / and EN46000 accreditations
Contact us with your specific task to get detailed information on how we will be of assisstance.
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