Regulatory Affairs

Regulatory Affairs Companies (63)

Regulatory Affairs News

Regulatory Affairs Products (55)

  • Product Services

    Aptar Pharma's specialized analytical, development and regulatory services contribute value throughout the entire drug development process, expediting progress and mitigating risks along the journey.

  • Product Biologic drug substance CDMO services

    From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...
  • Product Scientific Support

    Selectchemie AG provides a wide range of services including scientific support. Our experienced professionals are at your service at locations in 18 countries to deliver tailor-made solutions according to your needs. Contact us for more information.
  • Product CordenPharma Drug Product Support Services

    SUPPORT SERVICES FOR OUR CONTRACTED CUSTOMERS • Analytical Development • Validation Support • Regulatory Support • Clinical Supply Services
  • Product Cortellis HTA Intelligence™

    Increase successful submission outcomes in markets worldwide with comprehensive, expertly analyzed regulatory and market access information 1. Get treatments to patients faster Compare and monitor regulations quickly across markets to understand regional health technology assessment (HTA) outcomes. 2. Main...
  • Product Regulatory Affairs

    Continuous evolution in science and changes in the regulatory environment and health sector, creates the need for professional regulatory guidance throughout the lifecycle of a healthcare product.

    Our 20 years of experience in multidisciplinary projects, along with our team’s continually grown k...
  • Product Hi-End Resource On Demand Solutions

    Project resource management includes forecasting the need to hire and/or outsource some tasks. When projects are high-value and require strategic decisions, in-house resources may be insufficient. Similarly, administrative action items are better left to contract workers so as to not overburden your staff....
  • Product Regulatory & Market Access

    With the growth in pharma manufacturing capability in Asia, each manufacturer nurtures an ambition to have their own footprint in the EU market. PharmSol, with its own setups in Germany and Malta, has created a platform which provides a comprehensive, integrated and seamless market access and supply c...
  • Product GBC Production Plant site Video

    Genovior Biotechnology Corporation facility capabilities & current ongoing production lines
  • Product Formulation Development

    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.
  • Product Commercialization Services

    CARBOGEN AMCIS has a track record, extending over 25 years, helping our customers transition their molecules from process development through validation and ultimately into commercial status. A range of services backed up with fully integrated support functions has been developed to facilitate and smooth t...
  • Product Regulatory services

    For pharmaceutical products, we offer support for regulatory services such as:
    registration via national and European Union procedures;ANDA registration;
    drafting of e-CTDs to create e-CTD sequences;
    regulatory compliance;
    minor and major variations (evaluation and/or management).For ...
  • Product Medical & Regulatory Services - Inhaled Products

    Our formulation, device and development services are supported by our medical, regulatory, device vigilance and pharmacovigilance teams to safeguard your programme and ensure the smoothest path to product approval.

    Our in-house team can support with:

    Global regulatory development strategy...
  • Product Regulatory Services

    Our regulatory services team has decades of experience in obtaining and maintaining market authorizations and registrations. We ensure compliance of medicinal products, medical devices and food supplements during their complete life cycle. Currently we obtain compliance in 55 countries worldwide. Conta...
  • Product Wasdell QP Services

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

    GXP audits performed by industry experts.
  • Product e-Dox: management of eCTDs

    e-Dox: management of eCTDs

    OP Pharma has been providing innovative services in the Regulatory Affairs field for more than 20 years to small to big pharma Companies in Italy as well as in the European Union.

    Do you have dossiers of which you would like to outsource the management and u...
  • Product Development and engineering services by GEMÜ

    GEMÜ engages with its customers at an early stage and supports them in all aspects of product development. From conceptual design, mould engineering, material consulting to sterilization and regulatory support, we can provide all competencies in-house. In addition, our developments are supported by sim...
  • Product Research & Development and Regulatory Affairs

    In order to carry out its activities of R&D, prototyping and pilot batches preparation, Enable Innovations avails itself of a brand new production unit equipped with fully automated filling and packaging lines and laboratories complying with the most restrictive applicable regulations for medical devic...
  • Product Health, Safety and Environment Services

    Our experienced HSE experts offer various health, safety and environment services: Safety data sheet (SDS) support (SDS classification, labelling) in most EU languages, including online access and QR links; Controlled substances, precursors, highly active substances and other restricted chemicals (in-clud...

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