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 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 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 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 Quality - QEdge - Enterprise Quality Management Suite

    Sarjen Systems’ QEdge is an enterprise-wide Quality Management System (QMS) specifically designed for pharmaceutical manufacturing. This risk-based QMS offers a comprehensive suite of solutions, including:
    • Process Control • Document Control & Issuance • Training Management System • Ve...
  • 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 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 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 International Debt Collection

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

    Pediatric formulation and product development

    The development of acceptable, palatable pediatric formulations is a key feature within the industry today, driven by patient needs and regulatory requirements. Quotient Sciences has extensive knowledge and capabilities that enable us to provide you...
  • 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 AI and non-AI validation technologies for Life Science companies

    We specialize in IA and non-AI Computer System Validation, equipment validation, utilities qualification, and IT/OT infrastructure qualification. Our services comply with the regulatory standards of the EMA, FDA, WHO, and other key Life Science authorities across Europe and the Americas. With a proven trac...
  • 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 Klinea Pharmaceutical Engineering

    KLINEA is a company fully committed to providing added value solutions for the life sciences industry, specialized in Engineering Services, Project Management and Quality Scrutineering Tests, with offices in Madrid and Barcelona. Founded by a highly qualified technical team with more than 15 years of e...
  • 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 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 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 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 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 Auditing

    Our pharmaceutical auditing and management services give you a transparent view of your supply chain enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes. Through our shared audit programs, delivered by our global network of specialist audit...
  • Product CordenPharma Drug Product Support Services

    SUPPORT SERVICES FOR OUR CONTRACTED CUSTOMERS • Analytical Development • Validation Support • Regulatory Support • Clinical Supply Services
  • Product Serialization and Aggregation

    Bottle and blister lines fully serialized and aggregate.
  • 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 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 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 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 ANDA and NDA Technical Support

    As part of its commitment to full service support, Avéma Contract Services is pleased to offer our customers support with ANDA and NDA applications, including bio equivalency studies, collecting background data, supervising technology tranfers and reviewing applications to make sure that companies com...
  • 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 Cortellis HTA Intelligence™

    Increase successful submission outcomes in markets worldwide with comprehensive, expertly analyzed regulatory and market access information: 

    -Get treatments to patients faster Compare and monitor regulations quickly across markets to understand regional health technology assessment (H...
  • Product Development

    Synerlab provides wide range of services which includes development. Contact us for more information.
  • 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 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 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 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 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 Good Clinical Practice (GCP) auditing services

    Rephine provides a high-quality service in a timely and cost effective manner, from a single advisory activity to full GCP audits, or Quality Management programme and training. Rephine provides tailor-made solutions that meet the unique needs of your organisation.
    Rephine’s portfolio of GCP services i...
  • Product COMMISSIONING & VALIDATION

    CTP SYSTEM supports its customers in managing and directly performing all the Validation phases and Qualification activities for all kinds of equipment, systems and utilities in Pharmaceutical and related companies. 
    We have extensive experience in the preparation of Validation Master Plans at ...
  • Product REGULATORY AFFAIRS

    - Regulatory support
    - Political and social scenarios analysis within the Brazilian Health Sector- Market analysis to provide strategic information on the Brazilian Health System including public and private sectors
    - Regulatory intelligence strategy
    - Compliance
    - Due diligence
    -...
  • 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 Project Management

    Our experts incorporate the most modern and efficient Project Management techniques to ensure all project goals and objectives are met

    PharmEng Technology has recognized that Project Management is essential throughout the Pharmaceutical, Biotechnology, and Medical Device industries.
    ...
  • Product Synthetic Chemistry

    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.
  • Product Registration of Pharmaceutical products

    Registration of Pharmaceutical products in Algeria, Middle east and north Africa (MENA)
  • Product Precious Metal Recovery from Pharma Reactions

    Catalyst characterisation based on an extensive knowledge base and experience, will determine a tailored treatment process, which will deliver the best value returns. Understanding your process where the catalyst is utilised will help determine the treatment route and matrix effects, such as the residual ...
  • Product GMP Analytical development and validation services

    Our state-of-the-art laboratories offer a wide range of analytical services to support your exact needs under strict quality procedures which meet GMP requirements and following ICH guidelines.

    The analytical department provides support during the development of drug formulations combini...
  • 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 CONSULTING SERVICES

    SciencePharma is a leading, highly experienced consultancy company providing state-of-the-art services in a field of nonclinical and clinical studies. We gather a qualified team of experts, who carry‑out tasks from the various stages of projects/studies. As the consultancy company we deal with diversity is...
  • Product GMP Consultation

    Onsite/offsite gap analysis of the quality management system for pharmaceutical companies against Chinese GMP, cGMP, Eudralex GMP, PIC/S GMP, and WHO GMP guidelines; Provide recommendations on gap-bridging; Carry out mock up audits and assist in correction of findings; Provide onsite technical support and ...
  • Product Pharmintech Exhibition

    PHARMINTECH is one of the most important international exhibitions dedicated to processing, packaging and digital solutions for the Life Science industry.  PHARMINTECH welcomes you in Bologna from 10th to 12th April 2019.
  • Product U.S. FDA Registration & Listings

    Owners or operators of drug establishments that engage in the manufacture, preparation, propagation, compounding, or processing of drugs distributed in the United States are required to register and submit a list of every drug in commercial distribution in the United States.  Establishments located ou...
  • 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.