END TO END
REGULATORY AFFAIRS AND
We provide Regulatory Affairs, Clinical, Quality Audits, and Pharmacovigilance Services across the entire life cycle.
INDUSTRIES WE SERVE
Pharmaceuticals, Medical Devices, Cosmetics, Nutraceuticals, and Food Supplements.
GLOBAL REACH, LOCAL PRESENCE AND EXPERTISE
Local offices in USA, Asia, Latin America, and Europe.
Where We Are
Who We Are
We are a consulting company that provides a full spectrum of tailored Regulatory Affairs, Clinical, Quality and Pharmacovigilance Services to pharmaceutical, medical device, cosmetic, and neutraceutical companies worldwide.
Our main focus is to provide our life science clients with tailored services that meet their business needs, fit their budget and support their strategic growth globally.
Our team of professionals has decades of experience in Regulatory Affairs, Clinical, Quality and Pharmacovigilance, and has helped many life science companies register their products successfully and efficiently in USA, Latin America, Europe and Asia.
From our Blog
On March 2020, the Chinese health authority NMPA increased the registration fee of DMFs for APIs and added new registration requirements.
Global Regulatory Partners is Supporting the Fight Against Coronavirus (COVID-19) -Contact US to Learn More
FDA Emergency Use Authorization (EUA) for Face Masks Intended for a Medical Purpose, Surgical Face Masks and N95 Respirators
To increase the availability of Face Masks Intended for the protection of health care professionals the FDA will expedite the review of unapproved devices under the Emergency Use Authorization (EUA) process.
ANVISA clarifies that there are no conclusive studies proving the use of hydroxychloroquine and chloroquine as a treatment for COVID-19.
If you are a Medical Device, or Pharmaceutical that has the potential to diagnose or treat Coronavirus, you may qualify for FDA Emergency Use Authorization (EUA) in USA.
On March 18, 2020, FDA made widely available a new Guidance Document on managing clinical trials during the COVID-19 pandemic.