Regulatory Affairs

Regulatory Affairs
Product Description

The field of RA encompasses all the work necessary to manage products’ registrations and to receive and maintain marketing authorization.Choose PQE Group’s comprehensive support and broad strategic knowledge to launch products without delays and keep them on different worldwide markets.

PQE Group

  • IT
  • 2016
    On CPHI since
  • 1
    Certificates
  • 1000 - 4999
    Employees
Company types
Consultancy

PQE Group

  • IT
  • 2016
    On CPHI since
  • 1
    Certificates
  • 1000 - 4999
    Employees
Company types
Consultancy

More Products from PQE Group (8)

  • Audits

    Product Audits

    Due to recent regulatory developments concerning raw materials, suppliers, manufacturing and distribution, auditing has become a task of critical importance for Life Science businesses.PQE Group supports Pharma and MD companies in performing many types of certified audits, from routine monitoring to due di...
  • Data Integrity Assurance

    Product Data Integrity Assurance

    Data is a fundamental part of any Life Science production cycle and has become a major concern for global regulatory authorities.Choose PQE and ensure patient safety and business continuity within the entire product life cycle.
  • Digital Governance

    Product Digital Governance

    With new advanced technologies and new standards for Compliance and Cybersecurity, developing an intelligent network and infrastructure is a top level priority for Life Science businesses. Choose PQE Group’s all-in-one integrated solutions to coordinate your Corporate Digital Development.
  • Qualification & Engineering

    Product Qualification & Engineering

    The act of Validation, originally addressed only to sterilized equipment, now involves all product, process and facility matters.Choose PQE's solutions to ensure that your plant site meets your business objectives while being fully compliant with the latest Good Manufacturing Practice regulations and stand...
  • Quality Compliance

    Product Quality Compliance

    For Life Science businesses in highly regulated environments, compliance is not an option. Prepare to successfully pass inspections and design post-inspections remediation plans to achieve and maintain approval for your product with PQE Group's tailored and cost-effective programs for Quality Management.
  • Laboratory Excellence

    Product Laboratory Excellence

    We provide the expertise and counseling you need to secure the best lab performances and avoid recalls and non-compliances.Don’t risk losing quality and trust: choose the right training, guidance and support.
  • Technology Transfer

    Product Technology Transfer

    As we endure the echoes of the Covid-19 pandemic and, vaccine manufacturing companies face the need to expand the production to meet the highest rates of request in different parts of the world. To do so each company must rely on contract manufacturers to complete the production cycle. PQE can support this...
  • Advanced Remote Technologies

    Product Advanced Remote Technologies

    Our industry is rapidly evolving to cope with the challenges posed by new markets and the recent COVID-19 global pandemic that has systematically changed our working habits.Choosing PQE Group as your partner, you can perform audits, assessments, validation tests and training safely and remotely.

PQE Group resources (5)

Frequently Viewed Together

  • Product Custom Protein Synthesis

    We provide a Custom Protein Synthesis Service, using a chemical method that synthesises proteins amino acid by amino acid and making modifications on an atomic-scale. We work closely with our partners in designing, customising and optimising the proteins that is synthesized in an automa...
  • 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 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...
  • Product Health Authority Enforcement Response & Remediation

    • FDA/EMA/Health Authority Agency Intelligence • Rapid Response to Inspections • Remediation Support • On-Site Remediation Project Management • Coordination with Regulatory Counsel • Third-Party Support
  • Product IT/EU REGULATORY AFFAIRS - Support and management of Technical documenta...

    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 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 Development and engineering services by GEMÜ

    End-to-End Solutions for Cleanroom Plastic ManufacturingGEMÜ is your trusted partner for cleanroom plastic manufacturing, offering comprehensive development and engineering services tailored to the needs of medical technology, pharmaceutical packaging, and other highly regulated industries. We collaborate ...
  • Product Expert witness and intellectual property support

    Intertek offers wide range of pharmaceutical services which includes expert witness and intellectual property support for pharmaceuticals. It belongs to pharmaceutical and healthcare consulting services category. It includes expert witness and intellectual property support services, intellectual property s...
  • Product CordenPharma Drug Product Support Services

    SUPPORT SERVICES FOR OUR CONTRACTED CUSTOMERS • Analytical Development • Validation Support • Regulatory Support • Clinical Supply Services
  • Product Reference Materials Management Services

    To support you in bringing even safer medicines to the market, we go far beyond supplying you with the right reference standards. From impurity profiling and working standards outsourcing services, all the way to managing inventory and logistics of your reference standards, we’re fully equipped to provide ...
  • Product Regulatory Affairs

    We provide solutions to meet both local and global regulatory requirements in the most cost-effective manner.

    PharmEng supports Pharmaceuticals, Biologics, Over-The-Counter (OTC), Animal Health, Radiopharmaceuticals, Clinical Trial Products, Medical Devices, Combination Products, Natur...
  • Product Drug Development Consulting

    Our Drug Development Consultants work with you to design and implement successful drug development programs. With industry leading scientific expertise across a range of technical disciplines, we help customers across all stages of development, from candidate selection to commercial launch.

    Our cons...
  • Product Regulatory Affairs & Compliance Support

    Thépenier Pharma & Cosmetics offers comprehensive regulatory affairs and compliance services to ensure that all products meet global pharmaceutical standards. From dossier preparation to liaising with health authorities, the team ensures smooth regulatory approval processes. With expertise in GMP, ISO ...
  • 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 GO!FIVE Digital Validation Solution

    Global Verification & Validation is a SaaS solution for Life Science companies that complies with EMA/FDA. FIVE Validation developed a SaaS platform that allows AI and traditional validation studies to proceed 6x faster than a manual (electronic or paper-based) process.
  • 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 Services

    Midas Pharma offers wide range of pharmaceutical services which includes regulatory affairs services. It offers regulatory support for human medicinal products, veterinary medicinal products and herbal medicinal products in Europe. This includes: • drug substance services: development of ASMF/E...
  • Product Pharmaceutical drug substances (APIs)

    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 cust...
  • Product Laboratory Services

    Resource for optimal tableting: Medelpharm opened its brand new built-in laboratory in Spring 2017. The lab is under controlled atmosphere to perform powder characterisation and analysis. It houses amongst the latest innovative measuring equipment, the STYL'One Evolution Tableting Instrument, Smart test 50...
  • Product COMPLIANCE

    AUDITING: - Support its clients on Vendor Audit; COMMISSIONING:- Manages and performs commissioning activities for new systems, equipments and facilities; 
    TESTING:- Performs the following testing activities using its own instrumentation saving costs and time on tests planning; 
    COMP...
  • 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 Biocatalyst production

    Is the enzyme you are interested in not commercially available and a production needs to be developed? Enzymicals has extensive expertise with scale-up from lab to pilot-scale and technology transfers to industrial manufacturing sites. We can supply your protein by in-house production up to the kg-scale...
  • Product Regulatory Affairs

    Our team of Regulatory affairs experts make our service offerings stronger. 
    Following are our Regulatory offerings:

    • Regulatory Operations, Affairs

    • Regulatory Intelligence, Information Management COTS

    • Regulatory Strategy & Business Consulting

    • Health Autho...
  • Product Purcision™ - Platform for Direct to Target Drugs

    Purcision™ is a proven particle engineering technology used to develop new drugs and reformulate and repurpose existing drugs for multiple delivery systems.
    • Purcision technology is different from other particle engineering technologies (CESS, RESS, spray drying, milling)
    • Purcision technology ...
  • 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

    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 Licensing of Medical Devices

    Licensing of Medical Devices in Algeria and Middle East and North Africa (MENA)
  • Product Pharmacovigilance - PvEdge - AI Enabled Drug Safety Database Suite

    AI-enabled, cloud-ready,360 pharmacovigilance solution for safety database management. An end-to-end globally compliant safety software for Drugs, Devices, Vaccines and Combinational products from case intake to submissions and reporting. • Case Intake • Case Processing • Case Submission • Risk Manage...
  • 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 Research & Development of medical devices

    We provide a complete and comprehensive range of services from A to Z for substance-based  medical devices: from product idea, through development and research, certification, registration and product delivery to the customer.

    With us, you can easily launch a new substance-based ...
  • Product ENGINEERING

    CTP SYSTEM thoroughly knows how important it is to apply GMP requirements in pharmaceutical and healthcare fields. Our best solution for plant design in pharmaceutical industry combines profound respect of regulations and availability of resources, with the goal of quality for the final pr...
  • 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 Anklam Extrakt Poduct Portfolio

    • Premium Extracts – for your project Our extract portfolio includes both extracts in line with the ISO 22000 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 inn...
  • 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 Regulatory Support

    Armed with decades of experience and a mature Quality System, we collaborate with you to ensure your medical device is market-ready and complies to all latest industry regulations.

    Our capabilities and experience include: 
    - Fully integrated Quality System- Diversified & a...
  • Product PeP11 LabCal Excel Platform

    PeP11 LabCal offers a Single Validation SaaS Solution Platform that manages all Excel spreadsheets, eliminating the need for individual validations. This comprehensive electronic Excel solution features an Electronic Signature, Audit Trail, and Role-Based Access, rendering paper signatures unnecessary ...
  • Product Consultancy

    MFT Consult, our team combines deep expertise in regulatory compliance, facility design, QMS, and technology transfer with the ability to act quickly and efficiently. With decades of experience in the pharmaceutical and biopharmaceutical industries. we specialize in guiding startups in the pharmaceutical a...
  • 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 International Debt Collection

    Debt collection activities all over the world: we support Top European Pharma Groups, with extra-performances
  • Product DA Lawyers

    Life Sciences at DA Lawyers cares of the legal business needs of your company in Spain. Highly specializes in pharma distribution, we are your legal partners in your NDAs, Customer Protection Agreements, Distribution Agreements, Supply and Manufacturing Agreements, Agency, compliance issues, customs and...
  • Product Value-added generic development

    Avivia offers full product development services to generic drug companies and specialty pharma focused on the development of new improved versions (value-added generics or generic plus) of established drug products.
    Although in general the overall aim of value-added generic development projects is focu...
  • Product Serialization and Aggregation

    Bottle and blister lines fully serialized and aggregate.
  • 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 su...
  • Product FDA Compliance Monitor (Quality Assurance Tool)

    Automate your supply chain management.  The FDA Compliance Monitor allows you to easily identify vulnerabilities in your supply chain.   You can monitor the status of your own or your suppliers' FDA registration numbers as well as monitor for recalls, inspection results, warning letters, imp...
  • Product Pure steam humidifier Condair Esco

    Condair Esco is a pure steam humidifier which injects plant supplied pure steam through 100% leak-proof stainless steel control valve with stainless steel steam distributors. Condensate is continuously drained from the steam distributors to prevent microbial contamination in the air stream.
  • Product Development

    Synerlab provides wide range of services which includes development. Contact us for more information.
  • Product GMP-Support: Qualification / Validation / Consulting

    Quasaar does not see itself as "processing office" of service contracts.

    As an outsourcing partner, Quasaar also focuses on problem solving, increasing efficiency and process optimization, including on-site consulting and project management.
    Our expertise includes i.a. following topics: ...
  • Product Homogeneous Catalyst Precious Metal Recovery

    The increased use of Homogeneous catalysts in the pharmaceutical sector for reactions such as hydrogenation, asymmetric hydrogenation, reductive amination, carbonylation, dehydrogenation, isomerisation - Mastermelt have developed Metal Scavenger recovery systems to capture precious metals from these unique...
  • Product Rephine’s GMP Audit Reports

    Rephine provides personalised, detailed and comprehensive GMP audit reports that are recognised and accepted by QPs and regulatory authorities around the world. The Rephine list of audit reports is updated regularly.

    If the audit you require is not on the list, you can review the Rephine Audit P...
  • Product Consulting and advisory services for gmp, risk analysis, new product dev...

    Explicat Pharma GmbH offers consulting and advisory services for gmp, risk analysis, new product development strategypharmaceutical services. Contact us for more information.