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Regulatory Document Services
15 services found
Manufactured by:BCN Peptides S.A. based inSant Quintí de Mediona, SPAIN
BCN Peptides brings together a legacy of experience in successfully managing the complex regulatory and registration processes required for peptides. In addition to compiling and submitting regulatory documents for pharmaceutical substances in Europe, US and Japan, BCN Peptides also has extensive regulatory experience ...
Manufactured by:Viant Medical based inFoxborough, MASSACHUSETTS (USA)
We can help you engineer your tool or device, from complete process development, testing, and prototyping, to manufacturing documentation and regulatory compliance ...
Manufactured by:Precision Medical Products, Inc. based inDenver, PENNSYLVANIA (USA)
Once a device concept has been realized, it enters process design and development. PMP works closely with your team throughout this phase, adhering to design for manufacturing principles to ensure that the device can be produced at anticipated volumes. Are the right processes in place? The right materials? The right workflow? All of these factors must be considered — and verified — to ...
by:Ergomed based inSurrey, UNITED KINGDOM
Global regulatory framework assessment tool. This heat-map assesses the suitability of the country's regulatory framework based on your protocol. Simply enter details of your trial design to see which countries will facilitate fast approval and which ones will be more challenging. The fastest countries will be colored the darkest, more challenging the lightest and white where it's not possible. ...
Manufactured by:AGC Biologics based inBothell, WASHINGTON (USA)
AGC Biologics has a strong regulatory track record. We have been successfully inspected by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Danish Medicines Agency (DMA), the Paul Ehrlich Institute (PEI), Health Canada and the Pharmaceuticals and Medical Devices Agency (PMDA). The many audits and inspections conducted at AGC Biologics have helped us continuously ...
Manufactured by:Avania based inBrunswick, AUSTRALIA
We will partner with you to define, develop, document, and deliver a preclinical strategy, encompassing all aspects of product validation and verification, to bring your product to ...
Manufactured by:Avania based inBrunswick, AUSTRALIA
Our experienced team of therapeutically aligned medical writers support your product development by optimizing your presentation of clinical information with a wide variety of medical and scientific documentation. Our flexible services are available as part of your comprehensive program or as stand-alone assignments. ...
by:HAPILA GmbH based inGera, GERMANY
HAPILA GmbH is a company with many years of tradition in the synthesis and development of active ingredients. We have accompanied our partners from the idea on paper to clinical phase III for almost two decades. Some of our long-standing business partners still supply the market with medicines made from HAPILA active ...
by:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
Broad experience and access to the latest technological capabilities are essential for today’s increasingly complex API development and manufacturing. By partnering with Thermo Fisher Scientific, you’ll work directly with scientists with deep chemistry knowledge and many years of experience in successfully supporting early and later phase clinical development programs. Our experts ...
by:Emergo by UL based inAustin, TEXAS (USA)
It is easy to make mistakes in the regulatory process that can delay market entry or incur unnecessary costs. With help from Emergo’s medical device RA/QA consultants, you can pursue the most efficient regulatory route to approval and registration for your device, and maintain compliance with post-market requirements ...
by:Ascendia Pharmaceutical Solutions based inNorth Brunswick, NEW JERSEY (USA)
In the intricate landscape of biopharmaceuticals, development timing is a critical factor that can significantly impact the success or failure of a drug. Saving time can mean the difference between being first to market for a new drug class or a first-to-file ...
by:MMS Holdings Inc. based inCanton, MICHIGAN (USA)
Forward-thinking medical and regulatory writers that produce cohesive, scientifically-accurate, and regulatory-robust ...
Manufactured by:Thermo Fisher Scientific based inWaltham, MASSACHUSETTS (USA)
Natural killer (NK) cells are innate lymphocytes that kill virally infected or malignant cells. Unlike T cells, NK cells function in an antigen independent manner, responding to anything they perceive as "non-self", including malignant cells. NK cells are an attractive allogeneic immune modulator, as they have a well-known safety profile and lack the potential to cause graft-vs-host disease, a ...
Manufactured by:Resoundant, Inc. based inRochester, MINNESOTA (USA)
Resoundant offers Core Lab services in collaboration with the Mayo Clinic scientists and medical professionals who invented MR Elastography over 20 years ago. Today, Resoundant and Mayo Clinic continue to support the ongoing advancement of MRE through joint research and development activities. Resoundant Core Imaging personnel also hold joint appointments in Mayo’s MRE laboratory, and are ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
Biological formulation development involves discovering solutions for the most bioactive, native protein delivery. It poses a myriad of challenges due to the fact biologics consist of generally large, complex molecules that complicate drug development. Biologics are at the forefront of many current medical advances. They have established a key position in the pharmaceutical market by ...