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Regulatory Document Services In North America
10 services found
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 ...
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 ...
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 ...