Regulatory Affairs and Medical Affairs: Services beyond the ordinary!
We offer comprehensive regulatory/ medical support for human medicinal products, veterinary medicinal products and herbal medicinal products in Europe. From dossier compilation to registration and later life cycle management activities, our business-minded team ensures high quality work, but also keeps an eye on the implications for costs and time.
Our objective: The fastest approval at minimal costs.
We are specialized and experienced in:
- Medicinal products based on established API’s (e.g. small molecules or peptides) for generic – Article 10(1)
- OTC or value added medicines (e.g. hybrid) – Article 10(3)
- Mixed applications – Article 8(3)
- New fixed dose combinations – Article 10b
- Herbal and veterinary medicinal products
Our Service for Drug Substance contains:
- Development (preparation) of ASMF/EDMF and US-DMF
- CEP applications
- Life cycle management — variations, revisions, renewals
Our Service for Drug Product contains:
- Product development/ regulatory due diligence (also related M&A transactions)/regulatory strategies
- Pre-submission and/ or scientific advice procedures at regulatory authorities
- Dossier evaluation and gap analyses
- Writing chemical-pharmaceutical documentation (CMC, Module 3)
- Writing and review of clinical (CO) and non-clinical overviews (NCO)
- Compiling pharmacological-toxicological and clinical documentation
- Writing quality overall summaries (pharmaceutical-chemical expert reports)
- Preparation, submission and management of all types of Marketing Authorization Applications — national, centralized (CP), decentralized (DCP) and mutual recognition procedures (MRP)
- Preparation of product information (PI) - SmPC, patient information, labeling
- eCTD in-house publishing
Our team of highly qualified up-to-date regulatory affairs personnel includes pharmacists, biologists and chemists.
We have expertise covering a variety of therapeutic areas such as CNS, eye care, oncology, urology, gynaecology, gastro-enterology, cardiology, including different pharmaceutical forms such as oral, parenteral and sterile topical formulations.
We regularly assist small, mid and big pharma customers with our regulatory affairs services.
Your Contact
Dr. Robert Engering
Regulatory Affairs
Director
Rheinstr. 49
55218 Ingelheim
Germany