REGULATORY AFFAIRS
Product Description
Unica suporte científico e regulatório
-
BR -
2019On CPHI since
-
1 - 24Employees
Company types
Primary activities
Categories
Specifications
Unica suporte científico e regulatório
-
BR
-
2019On CPHI since
-
1 - 24Employees
Company types
Primary activities
More Products from Unica suporte científico e regulatório (2)
-
Product GOOD MANUFACTURING PRACTICES
- Quality Audits
- Risk assessment and management
- Review of Documents
- Training
- Preparation of technical reports
-
Product CLINICAL RESEARCH
- Support for strategic evaluations and regulatory alignment on clinical trials
- Qualification of study centres and researches
- Preparation of research protocols
- Preparation of Clinical Drug Development Dossiers (CDDDs)
- Monitoring of clinical studies
- Review of scientific literature
Recommended Products
-
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 Regulatory Sciences
From early-stage development to post-approval, we partner with pharmaceutical, biotechnology, and medical device clients to overcome regulatory hurdles. Using science as the driver for success, we help our clients achieve positive regulatory outcomes with the Food and Drug Administration (FDA), Europea...
-
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 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 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 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 Development
Synerlab provides wide range of services which includes development. Contact us for more information.
-
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...
-
.png)
Product Medical Cannabis Consulting
Experts in management and assessment of the production of medicinal cannabis.
The regulation of the cultivation and production of cannabis derivatives favours the emergence of a new industry with a large global market .It is estimated that the market for medicinal cannabis could reach 5...
-
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 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 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 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 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 R&D Laboratory of medical devices
Over 400 developed recipes,
including over 50 medical devices in various classes and indications,
in 20 pharmaceutical forms -
everything starts in the Gofarm's R&D Laboratory.
In Gofarm's R&D Laboratory our and our clients' ideas take real shapes...
-
Product Analytical Development
Recipharm offer analytical support for drug discovery, pharmaceutical development and manufacturing through our global development facilities.
-
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 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 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 Regulatory Affairs services
At Eignapharma we have a sound regulatory knowledge on the both national and international markets, providing support to our clients since 2010. Our experienced Regulatory Affairs team will listen to you and provide a tailored service, providing support to our clients in many different areas, suc...
-
Product On-body Injector
Phillips-Medisize collaborated with Subcuject to bring a ground-breaking wearable bolus injector to the market. This device is designed to be a low-cost, patient-friendly, pre-filled wearable injector for single-use.
-
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 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 GOOD MANUFACTURING PRACTICES
- Quality Audits
- Risk assessment and management
- Review of Documents
- Training
- Preparation of technical reports
-
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 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 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 Regulatory Affairs
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.
-
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 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 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 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 Licensing of Medical Devices
Licensing of Medical Devices in Algeria and Middle East and North Africa (MENA)
-
Product Cortellis Regulatory Intelligence™
Keep up to date with regulations, maintain biopharma regulatory compliance and make the right strategic decisions.
Navigate the regulatory landscape and efficiently drive strategic decisions
-Comprehensive repository of pharma regulatory intelligence Get full and time...
-
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 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 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 Formulation Development
We devise and implement product specific development strategies capable of delivering high-quality formulations and robust manufacturing processes.
To achieve our clients’ goal, several studies are performed as a means of achieving deliverables assigned to certain distinct development phases...
-
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 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 Regulatory Affairs Support
At Pattern of USA Inc., we’ve achieved seamless local regulatory compliance in over 130 countries, with centralized management based in the U.S. and project-based teams comprised of local professionals. This ensures solutions are tailored to diverse international regulatory requirements.
-
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 CordenPharma Drug Product Support Services
SUPPORT SERVICES FOR OUR CONTRACTED CUSTOMERS • Analytical Development • Validation Support • Regulatory Support • Clinical Supply Services
-
Product Pharma Regulatory Services
- Pre- and Post- Authorization Consultancy - Marketing Authorization Applications (NAP/DCP/MRP) - Life Cycle Management (renewals, variations etc.) - Submission of regulatory – related documents to Health Authorities - e-CTD submissions
-
Product Regulatory affairs services
I. SERVICES 1. Submission of ANDA, NDA and IND applications with NMPA; (including the whole service from GAP analysis, compiling, submission, sample testing, CDE review procedure tracking and supplemental info preparation); 2. GAP analysis and application strategies setup before the submission to NMPA; 3. ...
-
Product International Debt Collection
Debt collection activities all over the world: we support Top European Pharma Groups, with extra-performances%20(3)-comp323738.svg)
Recently Visited
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance