A short introduction to DADA Consultancy, your trusted partner in Pharma Support

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DADA ConsultancyCompany Presentation

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• DADA Consultancy is a premier and independent consulting agency

• Our aim is to provide state-of-the-art product development, regulatory affairs, clinical and pharmacovigilance/device-vigilance services and to establish long-term partnerships with our clients.

• At DADA we have a passion for detail while maintaining focus on our client’s ultimate goal

Introduction

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• DADA was established in 1984 and is based in the Netherlands

• Human and veterinary medicinal products• Medical devices and nutraceuticals• Cosmetics and herbal medicinal products • Covering all European Member States and related

regulated markets

Introduction

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• Pharmaceutical development– API– Finished Product

• Clinical Support• Regulatory Affairs• Pharmacovigilance• Medical Devices• ADOH

– Acting as MA holder– EU batch release service

Services

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Pharmaceutical development

• Complete product development: from API to finished medicinal product – network of contract laboratories and manufacturers

• Tailor-made project management– tight cooperation with regulatory and clinical experts

ü Over 60 product development projects delivered

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Clinical support

• Extensive experience in writing clinical and non-clinical overviews

• Designing clinical programs – writing clinical trial applications – selecting the appropriate CRO – writing the required documentation– auditing clinical studies and CROs

• Scientific advice

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Regulatory Affairs

• Independent and optimal advice on the best suitable RA strategy

• Writing complete application dossiers– human and veterinary medicinal products

• Running various registration procedures in EU • Handling required variations and update submissions

ü Written and submitted over 700 state-of-the-art marketing application files

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Pharmacovigilance

• QPPV services with approved PV system • Individual case or periodic reporting of safety

information to the applicable authorities• Local contact point for patients/HCPs• Advise on or audit of PV system• Complete compliance with regulatory demands

ü Optimally monitor the benefit-risk balance of your products to safeguard your marketing authorisation.

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Medical Devices

• Upcoming New Regulations for Medical Devices and In-Vitro Diagnostics

• Revision 4 of MEDDEV 2.7/1 – Clinical Evaluation• Increased scrutiny and stricter requirements• DADA expertise used for clinical and vigilance support

is now also dedicated to medical devices

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Medical Devices

• Clinical services– Feasibility study– Advise on the need for

clinical trials– Clinical study support– Comprehensive

literature search and review

– Assessment of clinical data

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• Vigilance services– Pre-market and post-

market reporting of incidents

– Field Safety Corrective Actions

– Periodic summary reporting

– Post-market clinical follow-up studies

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• Differences between countries in RA requirements despite EU guidance

• Old biostudies – ISR• Determining reasons for failed BE studies• Sterile products and unconventional sterilization

methods• Deviations and OOS

investigations, GxP CAPAs• Risk Management Plan updates

Problem solving

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Examples:

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ü Successful development of > 60 new productsü Successful compilation and submissions of > 700

applicationsü Fully compliant PV system, with EU-QPPV,

PSMF/DDPSü ISO 9001 certification

Successes

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• Experienced auditors– GMP– GCP– GVP

• Performing audits

• Preparing customers for inspections

GxP

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• Contact

• Telephone: +31 24 373 03 09• Fax: +31 24 373 00 46• e-mail: [email protected]• Web: www.dada.nl

Office

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Godfried Bomansstraat 316543 JA NijmegenThe Netherlands

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Icelandic Office

Hrund klínísk ráðgjöf ehf.Arna Hrund ArnardóttirSelvað 7110 Reykjaví[email protected]. 625 7787

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Polish Office

Dada PolskaEwa SzczecinskaUl. Rycerska 583-200 Starogard Gdań[email protected]

24 October 2016DADA Consultancy B.V.