Insights
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Case Studies
New Medical Devices Registration in ROW Countries
An EU medical device manufacturer was looking to expand its market beyond Europe for a new medical....
Celegence Deploys Centre of Excellence Model to Streamline Regulatory Activities
Celegence Deploys Centre of Excellence Model to Streamline Regulatory Activities
IDMP Proof-of-Concept
A global top 5 pharmaceutical company was looking to evaluate an IDMP solution including core application functionalities...
Company News
Celegence Holdings LLC Announces a Global Partnership and Investment in Soterius, Inc.
Celegence Holdings Announces a Global Partnership in Soterius, Inc. Celegence establishes partnership through a strategic investment in Soterius, creating efficiencies and growth opportunities
Celegence Partners with Performance Development Group to Help Life Sciences Companies Maximize their RIMS ROI
Press Release: Celegence Partners with Performance Development Group to Help Life Sciences Companies Maximize Their RIMS ROI Strategic partnership allows life sciences companies to
Celegence and ArisGlobal Partner on RIMS and IDMP Business Process-as-a-Service Offering
Press Release: Celegence & ArisGlobal Partner on RIMS and IDMP Business Process-as-a-Service Offering Strategic partnership between Celegence and ArisGlobal enables Life Sciences Companies to
Blog
Regulatory Challenges in Writing EU MDR Compliant Clinical Evaluation Reports (CERs)
Regulatory Challenges in Writing EU MDR Compliant Clinical Evaluation Reports (CERs): What the Changes Could Mean for Your
FDA Medical Device Registrations – 510(k) Submissions
FDA Medical Device Registrations - 510(k) Submissions Medical device manufacturers in the US can bring their products to market
Medical Devices with Ancillary Medicinal Substances (Combination Products)
Medical Devices with Ancillary Medicinal Substances - EU MDR The following is the sixth in the series of blogs