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Consultant Partner

515 Consulting

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

Asphalion

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.

Asphalion 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 the Asphalion staff combine experience in Drug Investigation and Regulatory Affairs, together with the dynamics of a young, specialized team.

Asphalion 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 Asphalion bases its success on KNOWLEDGE from EXPERIENCE.

Website: http://www.asphalion.com

Pharma-Labor

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.

Website: http://www.pharma-labor.eu

Quality PharmServ Romania

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/

SIPS Jordan

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/