515 Consulting Group provides expert advice and systems integration services to Pharmaceutical, Biotech and Medical Device companies throughout North America. Our advice and integration services include preparing for, selecting, implementing, validating and operating e-Regulatory applications including eCTD and RPS solutions. 515 Consulting can also help you with outsourcing your submissions, electronic or paper (eCTD, CTD, 510K etc.).

515 Consulting Group provides solutions and services for:

• eCTD

• RPS

• eCTD Authoring (Word) Templates

• Pharmacovigilance

• Document format validation

Our Services include:

• Software Installation

• Training (Product-based, technology based (e.g. eCTD etc))

• Submission Planning

• Submission Preparation (Assistance or Outsourcing)

• Software Validation

• IT Systems Validation

Customized services are also available. 

Website: www.515-Consulting.com

LogicaCMG is a major international force in IT services and wireless telecoms. It provides management and IT consulting, systems integration and outsourcing services to clients across diverse markets including telecoms, financial services, energy and utilities, industry, distribution and transport and the public sector.

Since 1995, LogicaCMG’s Business Units dedicated to Pharmaceutical Industry and Healthcare have acquired a broad range of expertise, capability and know-how that they can bring to bear to deliver success for its clients.

A wide range of services is offered that are well-suited to meet the needs of the market.   

References in the chemical and pharmaceutical markets: 

• nine out of the ten largest pharmaceutical companies (ranked on revenue) are LogicaCMG customers 
• in Europe over 800 LogicaCMG professionals work on projects at major pharmaceutical companies creating and replicating best practices 
• LogicaCMG’s MES solutions and services have been applied to optimise worldwide production of major life sciences companies 
• LogicaCMG has been successful in the design, implementation, validation and roll-out of regulatory document management solutions for SOPs, e-submissions and drug labelling for various leading customers in the chemical and pharmaceutical domain 
• LogicaCMG is one of the leading European providers of pharmaceutical validation services, spanning a wide range of solutions from preclinical research down to marketing and sales 
• LogicaCMG has performed surveys on topics such as ‘marketing efficiency in pharmaceutical industries’ with HEC and Pharmaceutiques Magazine 
• LogicaCMG’s portfolio encompasses various pharmaceutical specific offerings in different areas like R&D, manufacturing, marketing and sales. 

Website: http://www.logicacmg.com

orangeglobal is a highly specialised, independent healthcare service provider offering integrated services for all processes & workflows in the areas of
 

• HealthCare
• LifeScience
• Medical Device Technology

associated with international markets, multilingual solutions, IT applications and new outsourcing.

Are you in search just now of a partner to support you urgently in project management?

As project manager, you realise that you must hand over various jobs to a reliable and trustworthy partner in order to cope with the increasing pressure and to maintain quality in your core area of competence.

As decision maker, it is your duty to employ existing resources appropriately and release new resources. You must make business processes slimmer, faster and more economic. You are looking for a partner who is actively involved.

We do not see ourselves as consultants, but embody partnership. You entrust us with the responsibility in your business-critical processes and so reduce costs. We take over your processes effectively and efficiently and generate improvements through individual solutions. 

Website: http://www.orangeglobal.de/orangeglobal/en/home/home.html

Pharma-Labor GmbH is a company focused on consulting for all tasks around regulatory affairs and GMP.  Since 1988 the company is managed by pharmacist Mrs Yvonne Proppert. 

We are your independent partner in Germany to find solutions for your regulatory affairs or business projects. Our main focus is consulting in questions of mergers and acquisitions, licensing, business development, lobbying, business to business and in and out licensing to Middle East and North Africa. 

For German companies we find partners in the Middle East and North Africa and handle the complete registration work for a company and its products at Arab health authorities. For our Arab clients we allocate a GMP set-up in Germany and act as their partner in Europe for all questions arising. 

In detail we are experienced in:

GMP implementation, audits, pre-inspection approvals, supporting applications for GMP certificates and import licences for third party countries (manufactory site), preparation of set-up for companies from outside the European Union, support of business owners and CEO’s in all technical, regulatory and scientific questions. We take over key positions like qualified person, quality assurance, project management and interim CEO. We support and consult owners and management in regulatory and medical affairs  - from the first introducing till the cooperation with international pharmaceutical partners. Every step is based on expert-knowledge.  

Pharma-Labor GmbH has offices in Germany and Jordan, a GMP set-up with lab and warehouse and can fulfil all your needs as submitting your registration, drug release and also logistics for your pharmaceutical products. 

For every case, we will workout a solution.

Quality PharmServ is a company based in Romania, established in 2007, meant to serve the pharmaceutical field. Having in view the complexity of this field, we tried to welcome our customers with a very large range of products and services.

The products and services we are offering are covering a big part of the process through which a company will have a finished drug, staring with the designing of the manufacturing facility, endowing it with machinery and equipment for all manufacturing and research stages, consulting for elaboration of the GMP documentation an validations, continuing with active substances including the corresponding documentation, with specialized softwarefor compliation of the pharmaceutical dossiers in eCTD/ CTD format, with licensing-in offers for finished drugs or with srvices of Regulatory Affairs, and finishing with developing a new finished drug, business development, and so on.  

Website: http://www.qualitypharmserv.ro/

Our mission is to bridge knowledge and experience on best practice solutions and quality management in regulated life sciences for industry innovators: 

• Pharma Innovators: deliver fast through specialization

• Biotechnology: develop effective from alternative source

• Public Private Partnerships (PPP): develop and deliver cost effective to meet all patient / market needs 

By applying innovator principles ourselves:

• Build a highly effective and qualitative service delivery team
• Design industry solutions working with best practice tools and technologies
• Contribute to value add projects in a cost effective model
• Experience ‘rebirth’ while doing it...

Eventually, we want to contribute to value add life science and healthcare projects by bridging knowledge and solutions to where it is most needed (e.g. Essential drug development and Healthcare for developing countries) 

Value

We add value with business and IT consulting in specific expert areas relevant to the birth of a product (market authorization).

• Clinical Development
• Regulartory Operations
• Submission Management & Planning
• Safety

We translate vision and knowledge on best practice solutions for starting and fast growing life science companies and partnerships.

We have build our expertise in content management by working with the best practice software vendors.

We reduce cost with efficiency and direct results by using proven methods and tools for implementation, validation and support of business critical applications and procedures. 

Website: http://www.renascio.be

KNOWLEDGE FROM EXPERIENCE Your Partner for International Regulatory Strategy

REGULATORY AFFAIRS - DRUG DEVELOPMENT - BUSINESS DEVELOPMENT

Full Regulatory Affairs consultancy services: We assist pharmaceutical industries in Drug Development; Selection of partners, due diligence and new establishments.

Regulatory Pharma Net, combines a long experience in R&D management, acquired over many years within the Pharmaceutical Industry, together with a deep knowledge of Regulatory Affairs issues. The specialists in RPN staff combine experience in Drug Investigation and Regulatory Affairs, together with the dynamics of a young, specialized team.

RPN considers that only an updated knowledge, a thorough implication in each project and a long experience in R&D management constitute the bases to identify the clues and strategy in drug registration in our current globalized world. And this is the reason why RPN bases its success on KNOWLEDGE from EXPERIENCE.

Website: http://www.regulatorypharmanet.com

scarabaeusTEC ist ein hochspezialisiertes IT-Unternehmen. Wir entwickeln Software-Lösungen für die Pharma-Industrie, damit Medikamente und Arzneimittel noch sicherer und kostengünstiger hergestellt werden können. Unsere Zielgruppe sind nicht die Großkonzerne der Branche, sondern die vielen mittelständischen Pharma- und Biotech-Unternehmen, die ganz besonders auf optimale und kostengünstige Lösungen angewiesen sind. Seit über 15 Jahren haben wir uns auf Pharma-Lösungen spezialisiert und erfüllen nicht nur mit unseren Produkten, sondern auch mit unseren internen Abläufen und Dienstleistungen die besonderen Anforderungen unserer Kunden und der kontrollierenden Behörden. Wir sind so in der besten Position, für unsere Pharma-Kunden genau der Partner zu sein, den sie in IT-Fragen brauchen. scarabaeusTEC - die Pharma-IT-Spezialisten. 

Website: www.scarabaeustec.de

SIPS is short for Science Forum for intellectual property & industrial services. SIPS was established in Jordan as limited liability incorporated company in 2000 and got it’s name SIPS in 2002 with territorial extension to most of the Middle East and North African countries. . The main activities of SIPS are Pharmaceutical, Chemical & Biotechnology Intellectual Property Rights, Pharmaceutical Market Authorization and Training. In this regard;

SIPS offers know how and procedure to all Arab countries pharmaceutical market authorization laws and regulations including complete dossier preparation management, compilation & submission up to grant. SIPS undertakes tasks on all stages of regulatory requirements for drug approval. SIPS Patent related services include Pharmaceutical related Consultation & Product Registration, Industrial know–how and data protection, Patent & Know-How license arrangement & offers full cycle management on topics like Product Development, Product Management & Product Licensing Management. 

Website: http://www.ipjordan.com/