PharmaLex offers tailor made solutions:
we can either manage your whole registration
process or only parts of it. It’s your choice.
Registering with us.
We can manage either parts or the whole of your registration process. It’s your choice. For example: Mutual Recognition Procedures in the EU (MRP, DCP), National registrations, Centralised Procedures (CP), DMF and CEP processes, CTAs, Variations and Renewals. For EU registrations our network of local offices and partners provide a trouble-free registration.
Our expertise includes medicinal products:- NCE
- Generics / Biosimilars
- Biotechnological products
- Orphan drugs
- Phytotherapeutics
- Traditional medicines
- Homeopatics
- Veterinary drugs
Together with
- Medical devices
- Food supplements
- Cosmetics
What we offer
Before registration
- Registration-based product classification
- Product development strategies
- Pharmaceutical
- Toxicological
- Clinical
- Regulatory
- Marketing strategy
- Reimbursement strategy
- REACH
- Risk Management
Strategy-related tasks:
- Application for clinical trials (CTA, IMPD, IND)
- Evaluation of documentation on the basis of existing rules and regulations (Quality, Efficacy, Safety) and the supervision of related tasks
- Writing of individual Modules of the CTD (chemical-pharmaceutical, pharmacological/toxicological, clinical)
- Writing of Quality Overall Summaries, Nonclinical Overviews, Summaries and Clinical Overviews, Summaries
- Medical writing
- Writing of Active Substance Master File / European Drug Master File (ASMF/EDMF) US-DMF
- Preparation of SmPC, Patient Information, „Labeling“
- Patient consultation (PIL „User Test“)
- Preparation of Briefing Packages for meetings with authorities
- Scientific Advice Procedures (national authorities, EMEA, FDA)
- Compilation of the complete CTD eCTD dossier Module 1-5
During registration
- Preparation and submission of the dossier
- Supervision of the official registration process
- Communication with the authorities
- Responding to deficiency letters
- Translation of product texts into local languages
- Meeting mandatory timelines
After registration
- Life cycle management
- Adherence of regulatory compliance
- Reformating (NTA to CTD)
- Renewals
- Variations
- Line Extension
- Pharmacovigilance, PSURs, AE Reporting