Regulatory Affairs praca | Baza pracodawców Regulatory Affairs
Poniżej znajdziecie listę polskich i światowych firm outsourcingowych zajmujących się Regulatory Affairs.
Jeśli pominęliśmy firmę, która powinna znaleźć się w zestawieniu, daj nam proszę znać: kontakt[@]karierawfarmacji.pl
nazwa firmy
siedziba
informacje o firmie
Aixial
Experts to assist you in dealing with a regulatory environment that is constantly evolving and ever more demanding regardless of your area of activity. Website.
APC Instytut
Warszawa
APC Instytut jest członkiem organizacji EuDRAcon – międzynarodowej sieci zrzeszającej firmy zajmujące się Rejestracją Leków (Regulatory Affairs). Strona www.
ASPHALION
Barcelona
Asphalion is an international Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid, Munich and Amsterdam. We collaborate with Pharma and Biotech companies facilitating Drug Development and Regulatory Affairs projects for Drugs, Biologics, Biosimilars, ATMPs and Medical Devices. Our involvement ranges from early development, throughout registration, until marketing and post-commercialization phases. Website.
Awafarm s.c.
Warszawa
AWAFARM s.c. jest firmą konsultingową działającą od 2003 roku. Trzon pracowników stanowią byli pracownicy Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych posiadający wiedzę z zakresu rejestracji leków oraz farmacji, farmakologii toksykologii i medycyny, co daje gwarancję profesjonalnej pomocy dla firm farmaceutycznych w merytorycznym przygotowaniu dokumenatcji rejestracyjnej. Strona www.
Biomapas
Our full range regulatory affairs solutions and services are dedicated to delivering the highest quality support, assistance and regulatory approvals. We follow the needs of our customer and their portfolios, as we work with a wide range of product categories: medicinal products, medical devices, cosmetics, and food supplements. Our Regulatory Affairs team has comprehensive expertise and assures quality and accuracy for each task. All team members have majored in life sciences. Website.
BlueReg Group
Paryż
Consultancy Organization offering strategic Regulatory Advice and Outsourcing Solutions to Life Science companies. Website.
Cambridge Regulatory Services
Cambridgeshire
Cambridge Regulatory Services is a full service regulatory affairs consultancy helping pharmaceutical companies get their medicines to market faster. Website.
Cebis Int.
Szwajcaria
Offering a full set of services in clinical research and regulatory affairs, CEBIS is a cost effective and reliable partner, having multiple competitive advantages that are impacting positively the development of new products. We have 30+ years of experience in clinical research and our expertise and know-how together with utilising standard validated procedures and total quality management tools are oferring to our clients accurate and in-time deliveries. Website.
ClinicPharma
Piastów
ClinicPharma to nowoczesna firma konsultingowa o wieloletnim doświadczeniu w świadczeniu kompleksowych usług dla przemysłu farmaceutycznego. Specjalizujemy się m.in. w rejestracji produktów leczniczych, wyrobów medycznych, a także suplementów diety. Pomagamy również w przygotowaniu badań klinicznych leków i ocen badań biorównoważności. Nasze usługi wybrało wielu Klientów w Polsce (w Białymstoku, Krakowie, Poznaniu, Trójmieście, Wrocławiu, Łodzi, Lublinie czy Warszawie) oraz Europie. Strona www.
Diapharm
Niemcy
Managing medicinal product marketing authorisations and preparing and maintaining the documents to go along with them are our speciality. Diapharm has already handled more than 1,500 dossiers and Rx OTC switches. Website.
Dokumeds
Łotwa
Dokumeds offers a full range of regulatory services and expertise. From Clinical Development strategy, Regulatory Framework, to Clinical Trials Applications and Periodic Reporting, through to Marketing Authorization and Reimbursement Applications. Website.
Freyr
Regulatory Assessment, Market Authorizations, Post-Approval Changes, HA Query Management. Website.
G&L Scientific
G&L is a market-leading, multi-national, scientific consultancy with over 25 years at the forefront of Regulatory Affairs and Quality Assurance. Website.
Health-Med Sp. z o.o. sp.k.
Warszawa
We provide a support in the registration of medicinal products, veterinary products and medical devices. We offer Regulatory Affairs (RA) services at the pre-registration, registration and post-registration stages. Based on the acquired knowledge and experience in registration, we provide technical support as well as practical knowledge. Our services include: preparation of documentation, responses to comments or post-registration changes submission, including correspondence and direct contact with the registration authorities on behalf of the client. Website.
ICON
With a network of international experts and a customer focused approach, we are committed to delivering superior quality regulatory services that enable our clients to expedite drug development programmes. We work in partnership with our clients to maximise opportunities and meet key milestones on time and on budget.
iMEDGlobal (FMD K&L)
iMEDGlobal, an FMD K&L company, is an innovation-driven company providing platforms, services, and solutions to global life sciences clients to address critical business and scientific needs. Our platforms, services, and solutions include Pharmacovigilance, Regulatory Affairs, and Clinical Research. Website.
Insuvia
Kaunas
Insuvia is designed to act as a pharmacovigilance and regulatory affairs unit for pharmaceutical companies in those countries and regions, where they have no internal structures or decide to focus their resources on commercial activities. Website
Instytut Arcana
Kraków
Instytut Arcana, wychodząc na przeciw rosnącym potrzebom rynku medycznego oferuje obsługę procesu rejestracji produktów leczniczych poprzez przygotowanie oraz nadzór każdego etapu rejestracji. Website.
KMJ pharma® Sp. z o.o.
Łódź
KMJ pharma® Sp. z o.o. jest firmą specjalizującą się w usługach z zakresu rejestracji produktów leczniczych (syntetycznych, biologicznych oraz roślinnych), wyrobów medycznych, kosmetyków oraz środków spożywczych. Naszym głównym celem jest wsparcie firm z sektora farmaceutycznego, medycznego, kosmetycznego i spożywczego działających na terenie Europy, Ameryki oraz Azji. Świadczymy usługi w zakresie przygotowania dokumentacji nowych produktów, ich rejestracji i dalszego wprowadzenia do obrotu na rynku polskim. Strona www.
LINK Medical Research
Oslo
At LINK Medical, our Regulatory Affairs specialists provide full-service solutions for all our customer’s regulatory needs related to human and veterinary products, also including medical devices, medical gases, herbal medicinal products, food supplements and cosmetic products. Customers can take advantage of our flexible approach, outsourcing specialist services or inhousing regulatory specialists for both short-term and complex projects. Our services include regulatory strategies, gap analysis, preparation of dossiers, eSubmissions, review of marketing material, translations and life-cycle management. Website.
MAVEN
Maven has an expert regulatory team with very good knowledge of US, EU and ROW Regulations in Regulatory Strategy. Website.
mediReg
Warszawa
mediReg to młoda i dynamiczna firma. Posiadamy praktyczną wiedzę w zakresie przygotowania dokumentacji, prowadzenia procesów rejestracyjnych oraz interpretacji prawnych, nabytą w trakcie pracy w Urzędzie Rejestracji, zasiadania w grupach roboczych Europejskiej Agencji Leków (EMA) jak również w codziennym procedowaniu po stronie przemysłu jako specjaliści ds. rejestracji.
Neozene
USA
The Regulatory experts at Neozene can help your organization establish all processes necessary to meet all regulatory requirements. Whether these requirements are for regulatory submissions, licensure, general compliance, or training, our team of experts will efficiently and effectively establish or assist in establishing a regulatory infrastructure that will withstand scrutiny of any regulatory body in the world.
Parexel International Corporation; Inc
Warszawa, Kraków
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. Website.
Pharma D&S
Włochy
We support pharmaceutical companies in pharmacovigilance, clinical research, regulatory affairs and quality needs. Website.
PharmaBioServ
With over 27 years of experience, we provide world-class global consulting services to the Life Sciences Industry. Website.
PharmaDirections
USA
PharmaDirections is a consulting and project management company with a unique approach to managing preclinical, CMC and regulatory affairs programs. We provide strategic planning then oversee and direct pharmaceutical contract research using our own scientific experts and project managers. We are a comprehensive R&D resource for pharmaceutical and biotech companies who need more than just outsourcing of their API or drug product development. Website.
Phortas
Niemcy
We support our clients in navigating through regulatory and scientific requirements in developing new medicines. Our Regulatory Affairs consultants provide world-class expertise in all phases of a product’s lifecycle: from early development stage to marketing authorization and post-approval stage. Strona www.
Polfa S.A.
Warszawa
Dbając o kompleksową obsługę sektora farmaceutycznego oferujemy współpracę w zakresie rejestracji produktów leczniczych i utrzymywania pozwoleń produktów po ich zarejestrowaniu a także uzyskiwania certyfikacji suplementów diety, wyrobów medycznych oraz kosmetyków zarówno na rynkach krajów z poza obszaru Unii Europejskiej tj. Europy Wschodniej (Rosja, Białoruś, Ukraina, Mołdawia) albo Azji (Wietnam, Kazachstan, Kirgistan, Tadżykistan, Uzbekistan, Gruzja, Filipiny) jak i tych znajdujących się w obszarze Unii Europejskiej (Rumunia, Bułgaria, Węgry, Czechy, Polska). Strona www.
ProductLifeGroup
Delivering Regulatory, Pharmacovigilance and Quality Assurance services to Life Sciences companies and their global affiliates across the product life cycle through extensive outsourcing expertise and technical service support.
QP-Services UK Ltd
UK
Providing Technical Consultancy Services to the Pharmaceutical, Medical Device and Cosmetic Industries. Website.
QServe
We are a worldwide operating consultancy organization in the MedTech sector. We have supported hundreds of medical devices and In Vitro Diagnostics manufacturers with Global Market Access. We are highly specialized in Regulatory, Quality Affairs, Clinical Trials, and Training. Website.
Regulatory Pharma Net – RPN
Włochy
Regulatory Pharma Net (RPN), founded in 1999, is a qualified Regulatory Affairs services and consulting company based in Italy RPN highly-qualified team includes regulatory affairs, drug development and pharmacovigilance experts. Website.
Regulatory Professionals
USA
RPI was founded in 1995 to serve the growing needs of small to mid-size, pharmaceutical, biopharmaceutical, and medical device companies, advancing the development and registration of their products worldwide. Website.
Reguliance
USA
For firms with limited experience dealing with the US Food and Drug Administration, Reguliance can assist in detailing the expectations of the FDA, its structure and operating logistics. We have hands-on practical experience working with the FDA, and together with our knowledge of their regulations and guidances, we can assist you in determining what regulations and requirements apply to your specific development project. Website.
Regulatory Affairs Hub
As a group of Regulatory, QA and Pharmacovigilance consultants we offer an array of services for small to medium-sized pharmaceutical companies. As the regulatory landscape is ever changing that extra help may be just what you need. Website.
SciencePharma
Warszawa
SciencePharma provides multidisciplinary services for pharmaceutical companies from all over the world (EU and outside EU) covering all aspects of regulatory affairs including pre-authorisation, post-authorisation as well as handling of registration process of medicinal products (human/veterinary) and medical devices. Company services cover all application types and various pharmaceutical forms, therefore you will get experience in the entire RA spectrum. We explore the ins and outs of registration procedures in order to choose the optimal solution to succeed authorisation in a clever way. Always looking for new talented staff with different backgrounds and academic achievements (pharmacists, physicians, chemists, biologists and other). Website.
S-CUBED
Our Regulatory Affairs team have extensive regulatory expertise encompassing new chemical and biological entities, as well as medicinal products containing established active ingredients, generic compounds and therapies for orphan indications. Website.
Sensilab
Konstantynów Łódzki
Wspieramy naszych klientów na każdym etapie rozwoju nowego projektu. W zależności od statusu rejestracyjnego doradztwo w zakresie Rejestracji obejmuje pomoc w opracowaniu tekstów na opakowania suplementów, weryfikację oświadczeń, transfer technologi bądź stworzenie pełnej dokumentacji w formacie e-CTD dla produktów leczniczych. Strona www.
TopPharm Consulting
Warszawa
Ze względu na fakt, że naszą firmę tworzą osoby mające praktyczne wieloletnie doświadczenie w rejestracji leków w Polsce i w Europie nabyte w Urzędzie Rejestracji i uzupełnione kilkunastoletnią obsługą firm farmaceutycznych w zakresie regulatory affairs, możemy pomóc Państwu w sprawnym przeprowadzeniu procesów związanych zarówno z rejestracją leków, rejestracją wyrobów medycznych, czy rejestracją suplementów diety i ŚSSPM/FSMP, jak również we wszelkich kwestiach związanych z utrzymaniem pozwoleń (zmiany, re-rejestracja itd.) i ogólnie rozumianym regulatory affairs w Polsce i EU. Strona www.
Vyomus Consulting
Indie
Regulatory & Product Development Knowledge Partners for Biopharmaceuticals, Medical Devices, Cosmetics & Speciality Food. Website.
