Category

Regulatory Affairs

 

Acquisition taps into the unknown treasures of the sea

Screening for new marine-derived functional ingredients and bringing new patented products to the market.

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A powerful new tool for the separation of charged species

A new analytical tool, Electrical Asymmetrical Flow Field-Flow Fractionation (EAF4) is showing much promise in biopharmaceutical and nanoparticle applications.

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Spanish CDMO invests €200k to protect clients' products

Investment will enable Idifarma to both serialise commercial batches manufactured by them for clients and offer standalone serialisation services.

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Featured suppliers

  • Corpus Medica, UAB
  • Recipharm
  • Eurofins Amatsigroup
  • Palladio Group SpA
  • Ginsana SA, trading as SFI Switzerland
  • Seratec
  • Inkemia IUCT Group
  • Jesalis Pharma GmbH
  • PQE Group
  • DCS Pharma AG
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Latest products

Regulatory & Clinical Affairs

PQE Group

Pqe srl provides wide range of regulatory affairs services which includes ra pharma. It supports customers through the entire drug regulatory lifecycle, providing a full range of regulatory activities. Our service begins with the development of the regulatory strategy and concludes with the editing, amendment...

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Regulatory Dossier Preparation

Accuprec Research Labs Pvt. Ltd.

•      Preparation of CTD & e- CTD Dossier for countries like

USA, Canada, Europe, Brazil.

•      Preparation of Dossier for Allopathic Formulations as

well as Herbal Formulations also.

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Export of Pharmaceuticals

Jesalis Pharma GmbH

from Germany and EU to

  • Asia-Pacific
  • MENA
  • Latin America
  • Africa

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Anklam Extrakt Poduct Portfolio

Anklam Extrakt GmbH

Premium Extracts – for your project
Our extract portfolio includes both extracts in line with the HMPC and/or Ph.Eur monograph for the pharmaceutical industry, and extracts for the food industry.
From A for Althaea (marshmallow) to V for Vaccinium (cranberry) - we offer you a sophisticated and innova...

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Regulatory Affairs

Mapi Group

Regulatory Affairs

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Wasdell QP Services

Wasdell Group

Our dedicated QP Services team are able to provide compliance support, audit services, regulatory consultancy and QP certification for imported medicinal products.

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Technical & Regulatory Services

galien+

Industrial Expertise

Technical and Scientific supports

Technical writing of Dossiers and variations

Post marketing authorization maintenance support Services 

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Synthetic chemistry

Recipharm

Recipharm offer a range of synthetic chemistry services through our global development facilities including advanced lead optimisation medicinal chemistry, process development and tech transfer to large scale GMP-manufacturing and other specialties.

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Scientific and Regulatory consultancy

Inkemia IUCT Group

Inkemia IUCT Group offers a wide range of services which includes consultancy service. Features: it includes Assessment in the implementation of GMP, GLP, ISO, HACCP; patent drafting; Drug Master File; Intellectual Property; Technical reports; bibliograqhical research; expert reports and scientific abstracts...

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Pharma Partners Ltd

Palladio Group SpA

Officina Farmaceutica was born as a workshop of drugs secondary packaging. In 2010 it has been certified ISO 13485 for Secondary packaging ofmedical devices and diagnostic products. Recently, Pharma Partners has been authorized to the transformation from product sales to free sample and to the reworking of ba...

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Qualified Persons

PCI Pharma Services

Qualified Persons (QPs) play a vital role in bringing products to market within Europe. Global clients look to the diverse range of skills and specialisms of our highly experienced team of QPs to ensure their clinical studies not only meet the most rigorous standards but also run smoothly, seamlessly and cost...

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Pharmaceutical drug substances (APIs)

Seratec

Seratec specializes in fine organic chemistry and is dedicated to active pharmaceutical ingredient (API) development & production for the pharmaceutical industry.
Seratec operates in highly regulated markets and where high quality products are critical.
Seratec offers a complete range of custom ...

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Analytical development

Recipharm

Recipharm offer analytical support for drug discovery, pharmaceutical development and manufacturing through our global development facilities.

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Clinical Supply

Recipharm

Recipharm have more than 20 years experience supplying clinical trial material to our clients. Our development facilities cater for a range of clinical trials from preclincal to smaller Phase III trials. We also offer commercial manufacturing for very large clinical batches.

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Consulting

Jesalis Pharma GmbH

Regulatory Affairs

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Formulation Development

Recipharm

Recipharm offer formulation development services for all dosage forms. We develop everything from simple formulations for early studies to more complex formulations suited for commercialisation.

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Regulatory Affairs

Mapi Group

Our talented team of experienced consultants have the technical and regulatory experience to address your Chemistry, Manufacturing & Controls (CMC) projects and expedite your company’s regulatory and quality programs.

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