SubscribeEvery day PharmaLex experiences what it means to bring a medicine onto the market. Innovation, ideas, hard work, persistence and patience, as well as strategy, coordination and interdisciplinary thinking is what is needed to get a new product through research and development.
Keeping ahead of the competition
PharmaLex Inter-national provides specialised support for drug registration so that you can bring your drugs onto the market in Europe, Australia, or the Americas in a rapid and uncomplicated way.
Drug registration is a continually evolving process and is becoming technically more complicated. The pressure on drug registration becomes evermore intense. The legal requirements change on a near daily basis and the technical demands for registration constantly increase. The evolution of the elec-tronic submission means that in the future the whole registration procedure will eventually be entirely electronic.
PharmaLex's registration experts are pharmacists, medical scientists, chemists, and biologists who make sure that you have optimal support for all aspects of your drug registration. It should not be un-derestimated how a mistake in the registration process can block a drug from reaching the shelves for months or even years. Valuable time is easily lost which is something no one can afford in today's highly competitive global markets.
A lot of time can be lost when registering a drug because of a lack of optimal coordination among dif-ferent departments. For instance the pharmaceutical development or the delivery of the clinical trials reports may not be according to schedule. Our advice: put your drug registration in our hands.
PharmaLex will gladly take over the coordination during and after the registration process. Our regis-tration experts are pharmacists, medical scientists, chemists, and biologists who make sure that you have optimal support for all aspects of your drug registration. We know how to manage the interdisci-plinary tasks so that the different departments of your company can work efficiently together. We are supported by a network of experts in pharmaceutical, pharmacological, toxicological, clinical (CRO) areas, production and sales.
The professional touch for the final finish
As your partner we are always proud when a PharmaLex registration dossier is given the green light from the authorities. This means that we made a decisive contribution to securing the success of our client's high investment in product development. We succeed because we leave nothing to chance. Our registration checklists are not only an aid for us, but bring structure to departments on the long route through the authorities. In the end it is your innovation that finds its way rapidly and quickly onto the market.
PharmaLex was founded in 1998 by experts working in Regulatory Affairs at Boehringer Mannheim after years spent dealing with complex drug registrations in a commercial environment. The idea to support the pharmaceutical industry in drug registration met with instant success and with registration procedures becoming increasingly complex, PharmaLex has grown into a dynamic and successful company.
Today PharmaLex is one of the largest companies offering worldwide drug registration services. The success is not by chance because our clients:
- Profit from reducing the time it takes to submit a registration dossier
- Can register new products quickly and reduce the time it takes to bring them to market
- Increase their revenues and profits
- Significantly reduce the burden on internal departments responsible for registration
- Gain a competitive advantage over the competition
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 can do for you?
Before registration
- Registration-based product classification
- Product development strategies
- Pharmaceutical
- Toxicological
- Clinical
- Regulatory
- Marketing strategy
- Reimbursement strategy
- 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, pharmacologi-cal/toxicological, clinical)
- Writing of Quality Overall Summaries (QOS), 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
Registration consultants "on demand" - our solution to your backlog
Registration departments all suffer the same problems. In the rapid cycle of action and reaction during a registration process the short-term peaks in the demand for staff cannot be covered. Simply put, registration departments are always living on the edge and this can have major consequences for successful registration.
PharmaLex International has the solution to your problems. Our highly qualified registration experts can assist you in all fields. Our consultants will evaluate your documents in view of current rules and guidelines, compile a complete dossier (optional electronically), and supervise the entire process.
Alternatively we can offer you the "PEP" solution: PharmaLex Expert Partner. These are interim man-agers that can strengthen your team in-house and help to accelerate the registration process. We can even provide you with a PEP on a long-term basis. If you require a "Qualified Person" a "Drug Safety Officer" or "Information Officer", we can help.
Hong Kong, Brazil, and even in Quatar - we know the value of local knowledge
Ever since the Thalidomide disaster of the late 1960s there has been a worldwide effort to increase drug safety via standardised registration procedures. Despite this drive for harmonization, registering a new drug is still an arduous task in many countries. Legislation is only one of the problems. More fre-quently it is national idiosyncrasies that cause delays. It starts with language and continues to different cultural approaches and working procedures.
This is why PharmaLex has offices or contact partners in most EU countries. PharmaLex staff has a full command of the local language and know the ins and outs of national authorities. This means that we can react quickly when need be and anticipate potential problems. Naturally our offices in Asia and the USA can also be of assistance to you. PharmaLex has successfully compiled registration dossiers in more than 100 countries.
PharmaLex International- The relaxed route to worldwide drug registration.
How can PharmaLex be of help to you?
We can manage all your registration needs:
from a CEP- or CTA-procedure to a Centralized registration. Do not hesitate to call us!
PharmaLex GmbH
Joseph-Meyer-Str. 13-15
D-68167 Mannheim
Tel. +49.621.18 15 38-0
Fax +49.621.18 15 38-20
info@pharmalex.com