PharmaLex International Drug Registration Management Services

PharmaLex International supports drug applications, enabling rapid registration in Europe, the US, Japan and other regions worldwide.

PharmaLex’s regulatory affairs experts are pharmacists, medical scientists, chemists and biologists who make sure that you have optimal support for all aspects of your drug registration.

PharmaLex knows how to manage the interdisciplinary tasks so that the different departments of your company can work efficiently together. To cover the whole process PharmaLex relies on a network of experts in pharmaceutical, pharmacological, toxicological and clinical (CRO) areas, as well as production and sales.

Expertise in mutual recognition procedures (DCP, MRP), centralised procedures, DMF and CEP processes, and CTAs

Based on more than 20 years of regulatory affairs experience, PharmaLex elaborates the most promising strategies when launching your product on the market.

PharmaLex’s highly qualified registration experts assist in all fields of regulatory affairs; for example, evaluation of documents in view of current rules and guidelines, compilation of the complete dossier (paper-based or electronically – eCTD) and the management of either parts of or the entire registration process. Mutual recognition procedures in the EU (MRP and DCP), national applications, centralised procedures (CP), DMF and CEP processes, CTAs, variations and renewals are all covered by PharmaLex’s expertise. For EU registrations PharmaLex’s network of local offices and partners ensure a trouble-free registration.

Areas of expertise include medicinal products for human and veterinarian use, such as NCEs, Generics, ATMPs, biotechnological products, biosimilars and phytotherapeutics, as well as medical devices, food supplements and cosmetics.

Pharmacovigilance strategies for drug registration

PharmaLex’s experts develop and implement custom-tailored Pharmacovigilance strategies for your medicinal product as well as for your medical device, from early clinical stages through pre-marketing, up to the established Pharmacovigilance activities in post-marketing stages. In addition, during the approval process we provide the safety specification, detailed description of Pharmacovigilance system (DDPS) and EU risk management plan (EU-RMP) to be submitted at the time of licence application of your drug.

Paediatric investigations

PharmaLex assists you in all issues concerning paediatric investigations. Experts sort your current documentation and investigate the existing studies for your intended paediatric indication. PharmaLex evaluates the results of the studies and writes expert reports, supports your strategic planning and evaluates the potential for deferral or waiver, and compiles your PIPs or PUMAs.

Custom-tailored drug registration services

PharmaLex manages either parts of or the whole of your registration process – it’s your choice. Besides competent consultancy, the strategy-related tasks include:

  • Application for clinical trials (CTA, IMPD and IND)
  • Evaluation of documentation on the basis of existing rules and regulations (quality, efficacy and safety) and the supervision of related tasks
  • Writing of individual documents of the CTD-modules 2-5 (chemical-pharmaceutical, pharmacological / toxicological and clinical)
  • Writing of quality overall summaries (QOS), nonclinical overviews, summaries and clinical overviews
  • Medical writing
  • Writing of Active Substance Master File / European Drug Master File (ASMF/EDMF) and US-DMF
  • Preparation of SmPC, patient information and labelling, PIL ‘User Test’
  • Preparation of briefing packages for meetings with authorities
  • Scientific advice procedures (national authorities, EMEA and FDA)
  • Compilation of the complete CTD, eCTD dossier Module 1-5
  • Company individual hosting of electronic dossiers (eCTD)
  • Training courses in all regulatory domains

During the registration process PharmaLex deals with the preparation and submission of the dossier, the supervision of the official registration process, communication with the authorities and translation of product texts into local languages. PharmaLex also responds to deficiency letters and meets mandatory and company-defined timelines.

Life-cycle management, regulatory compliance, renewals and line extension

After drug registration, PharmaLex provides guidance and expertise regarding:

  • Life-cycle management, paper-based or eCTD-LCM
  • Adherence of regulatory compliance / maintenance
  • Reformatting (CTD to eCTD)
  • Renewals
  • Variations
  • Line extensions
  • Pharmacovigilance, PSURs and AE reporting

About PharmaLex

PharmaLex was founded in 1998 by experts working for several years in regulatory affairs at Boehringer Mannheim dealing with complex drug registrations in the commercial environment. The idea to support the pharmaceutical industry in drug registration met with instant success, and as registration procedures have become increasingly complex PharmaLex has grown into a dynamic and successful company.

Today PharmaLex is one of the largest companies offering worldwide drug registration services, and has successfully compiled registration dossiers in more than 100 countries.

Make an enquiry

Follow this company

Follow the company to be always up to date with this company

Press Release

PharmaLex International to Participate in EU Marketing Authorisation – Update on Generics, Variations and eCTD Forum

PharmaLex International is to participate at the EU Marketing Authorisation - Update on Generics, Variations and eCTD Forum, which will take place in Sofia, Bulgaria, on 11 and 12 May this year. The schedule is as follows. Day one: 11 May 2010 Generics: full applic

Address
PharmaLex GmbH

Joseph-Meyer-Str 13–15

D-68167 Mannheim

Other

Germany

+49 621 18 15 38 0 +49 621 18 15 38 20 www.pharmalex.com Forthcoming events

PharmaLex International Images

Products and Services

Video

White Papers

Related Projects



Press Release

18 April 2010

PharmaLex International is to participate at the EU Marketing Authorisation - Update on Generics, Variations and eCTD Forum, which will take place in Sofia, Bulgaria, on 11 and 12 May this year. The schedule is as follows. Day one: 11 May 2010 Generics: full applic

Read more

Regional Offices

PharmaLex GmbH

Joseph-Meyer-Str 13–15

D-68167 Mannheim

Other

Germany

+49 621 18 15 38 0 +49 621 18 15 38 20 www.pharmalex.com Forthcoming events

Contact company

Close
Close
Close

Go Top