IWA Consulting - Healthcare Regulatory Affairs Consultants

IWA Consulting is an internationally recognised healthcare regulatory consultancy offering expertise in European registration procedures, new drug development, regulatory strategies, scientific advice, CTA, eIND, Investigator’s Brochure (IB), orphan drug applications and SME applications.

Lifecycle management and preparation of eCTDs

IWA Consulting has submitted more than 600 eCTDs, including all sequences. Lifecycle management (LCM) is a well-established procedure and the company has several employees trained in handling LCM, as well as preparation of eCTDs in a validated environment. Assistance is offered in preparation of eCTD compliant and hyperlinked documents.

IWA Consulting works with international partners and has close cooperation with partners in all EU countries as well as the US and India. These partners have been selected on their proven skills and a number of successful finished projects.

IWA Consulting is steadily educating its highly trained staff of experts, and ISO certification is expected to be granted in August 2009.

Regulatory affairs (RA) assistance in new drug development

IWA Consulting offers regulatory affairs (RA) assistance in the development of new drugs. IWA Consulting’s experts can assist with:

• Regulatory strategies
• Applications for scientific advice, including preparation of briefing documents and assistance in pre-meetings and actual meetings
• Clinical trial applications in Europe (CTAs) and in the US (INDs)
• Preparation of Investigator’s Brochures
• Preparation of orphan drug applications in the EU and the US, including assistance in pre-meetings and actual meetings
• Applications for fee deductions for small and medium-sized companies in the EU
• Fast-track applications (EU and US)

The EMEA offers small and medium enterprises the possibility of obtaining SME status. SME status is associated with various advantages, from financial incentives to procedural assistance. IWA Consulting offers assistance for application of SME status. For companies located outside the EEA, IWA Consulting offers the opportunity to obtain SME status through the IWA Consulting SME status.

RA assistance in preparation of readability testing, quality and non-clinical documentation, and CTD conversions

IWA Consulting offers RA assistance in preparation of:

• Module 1 administrative parts in the EU and the US in cooperation with local native speakers for national parts when required
• Readability testing in Danish, Swedish, Finnish and English via partners
• Modules 3 and 2.3 for quality documentation (chemical pharmaceutical documentation), as well as DMFs and EDMFs
• Modules 4, 2.4 and 2.6 for non-clinical documentation in cooperation with experienced toxicologists
• Modules 5, 2.5 and 2.7 compilation only; no writing
• CTD conversions from former notice to applicant’s format, including tabular overview of changes done during the conversion

RA submissions for biologic, synthetic, generic and well-established products

IWA Consulting offers assistance with RA submissions of biologic products, synthetic products, generic products and well-established products.

RA procedures: preparation of SPC, PIL and labelling, and responding to CMS comments

IWA Consulting has extensive knowledge of national procedures (NP), mutual recognition procedures (MRP), decentralised procedures (DCP) and centralised procedures (CP), including preparation of SPC, PIL and labelling for initiation of the procedures, and responding to CMS comments during the procedures in tabular format and updating the texts accordingly.

Maintenance of applications for registrations

IWA Consulting handles variations in the EU and supplements in the US; pharmacovigilance in cooperation with a local partner qualified at EMEA as pharmacovigilance QP and qualified for electronic reporting; maintaining labelling and patient information leaflets in compliance with local requirements; and translation from Danish to English and English to Danish using highly trained external translators with knowledge of the required standard terms and QRD templates.

E-compatible documentation for eCTDs

IWA Consulting can assist with the preparation of e-compatible documents, e-compatible Word templates, working routines (workflow / review cycles), final sign-off of quality-controlled documents, and working in dedicated protected areas facilitating long distance cooperation.

eCTD submission and lifecycle management

IWA Consulting can also assist with the preparation of hyperlinked eCTD submissions in a validated environment and lifecycle management of the eCTD.

EDMS and / or eCTD projects

IWA Consulting has expertise in:

• Implementation of EDMS and / or eCTD systems
• User requirement specification (URS)
• Working routines - workflow / review cycles
• Electronic archiving procedures (CTD)
• Physical archiving procedures (CTD)

Quality assurance

IWA Consulting offers assistance in the establishment of quality assurance systems (ISO 9001:2000), standard operation procedures (SOP) templates, review of SOP, and internal and external audits of QA systems.

IWA Consulting also maintains the national Danish module of TARIUS.