Category

Regulatory Affairs

 

Process innovation needs to be undertaken in early R&D phase

Much needed more efficient manufacturing processes for ADCs aren't being completed by pharma.

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Amneal to close it Hayward, California-based facilities and operations

Company to streamline operations and capture cost synergies.

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Cambrex invests $5 million in new laboratory expansion at its Karlskoga, Sweden facility

Money to be spent on augmenting capability and capacity for process development and scale up, handling of potent substances, crystallization studies and solid phase characterization.

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Featured suppliers

  • SciencePharma
  • Corpus Medica, UAB
  • Pharmaffiliates Analytics & Synthetics
  • Recipharm AB
  • PharOS Ltd
  • Famar
  • PQE srl
  • Eurofins Amatsigroup
  • SFI Switzerland
  • Palladio Group SpA
Browse all suppliers 

Latest products

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 innovative pro...

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REGULATORY AFFAIRS SERVICES

SciencePharma

We offer multidisciplinary services covering all aspects of regulatory affairs including pre-authorisation, post-authorisation as well as handling of registration process of medicinal products (human/veterinary) and medical devices across all application types and various pharmaceutical forms for EU markets. ...

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Regulatory & Clinical Affairs

PQE srl

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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Regulatory Affairs

ICON plc

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 AB

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 AB

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

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Clinical Supply

Recipharm AB

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 AB

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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