Regulatory Affairs

Regulatory Affairs Companies (49)

Regulatory Affairs News

Regulatory Affairs Products (40)

  • Product Services

    Our specialist analytical, laboratory and regulatory services add value at every stage of the drug development process, accelerating and de-risking program along the way.
  • Product Regulatory Support

    Avéma Pharma Solutions can help guide your product successfully through NDA, ANDA, CBE 30 and 505(b)(2) filings with the FDA.
  • Product Consulting: Quality Management System

    Quality management systems (QMS) are crucial for the success of any business. They provide an accurate way to track and measure quality across all areas of your company. One key benefit of a quality management system is that it establishes clear goals, roles, and responsibilities. It also tracks the pr...
  • Product GBC Production Plant site Video

    Genovior Biotechnology Corporation facility capabilities & current ongoing production lines
  • Product IT/EU REGULATORY AFFAIRS - Support and management of RA practices

    OP Pharma has been providing all-around 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.
    Our expertise ranges from submission of registrations, variations, prices, texts, renewals (also via CESP), to CEP and...
  • 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 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 Regulatory Affairs Support Services

    Rephine’s regulatory consultancy provides a complete portfolio of regulatory services to the pharmaceutical industry from clinical trial regulatory support to product life cycle management. Services include but are not limited to full clinical trial application (CTA) support, ...
  • 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 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 Consulting: ICH Q10

    Pharmaceutical companies must be capable of delivering products to the market with the utmost level of quality and safety. At Zamann Pharma Support, we have been aiding large and mid‐sized pharmaceutical companies in solving quality and compliance challenges while ensuring that practicality and qualit...
  • Product Life Science: GMP Process Support

    The compliance environment of the pharmaceutical and life science industry can offer very complex challenges. One issue is optimizing workplace technologies in the areas of Business Process Changes, Validation, and general GxP Compliance. At the same time, these challenges must be balanced with the develop...
  • Product IT/EU REGULATORY AFFAIRS - Support and management of Technical documentation and eCTD

    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.
    Our expertise covers the lifecycle management of pharmaceutical products, whole or in part, ranging from digitization ...
  • Product e-Reg: management of Regulatory Affairs' big data

    OP Pharma has been providing all-around 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 lots of products and/or products' data which you cannot organize/archive interna...
  • 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 Registration of Pharmaceutical products in Singapore

    We support clients to manage their regulatory portfolio in Singapore and other parts of SE Asia by rendering independent license holding, submission of dossier to health authority, regulatory intelligence works and project management. 

Upcoming Events

  • CPHI Japan 2023

    Tokyo Big Sight, Tokyo, Japan
    19 - 21 April 2023
  • CPHI North America 2023

    Pennsylvania Convention Center, Philadelphia
    April, 25-27, 2023
  • CPHI & PMEC China 2023

    Shanghai New International Expo Center
    19 - 21 June 2023

Pharmaceutical Industry Webinars