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Digital technologies and AI are transforming pharmacovigilance, clinical documentation (eTMF), and regulatory operations. What This Means for You: New functionality aligns with EMA, FDA, and ICH E6(R3) expectations for documented investigator review, endorsement, and sign-off of participant data MALVERN, Pa.,…
Upcoming GMP revisions emphasise digital traceability, data integrity, and supply-chain accountability. What This Means for You: Accelerate Your Pharmaceutical Career with GMP & GXP Training from SÜD TÜV ISO 9001-Certified Experts Stay ahead in the pharmaceutical industry by mastering GMP,…
The UK continues to refine its own regulatory pathways for manufacturers and wholesalers. This includes unique UK-only authorisations, labelling rules, and independent inspection schedules. What This Means for You: Update SOPs and technical agreements accordingly. Key points Here are some…
The European Commission is reshaping market-exclusivity periods, supply-chain duties, and orphan-drug incentives through the upcoming “Pharma Package.” What This Means for You:
Insights curated by GLORAMP Pharma Consulting LtdStay informed with the most recent developments from leading global authorities — EMA, MHRA, FDA, CMDh, and EDQM — plus key regulatory shifts affecting pharmaceutical operations, pharmacovigilance, quality systems, eTMF management, and QP batch…
European authorities are tightening requirements around medicine availability and environmental sustainability. What This Means for You: Introduction: EU pharma industry expectate new regulations changes in the year 2025. European Medicines Agency (EMA) and other regulatory authorities in the continent gradually…
The EMA’s Committee for Medicinal Products for Human Use (CHMP) reviewed several marketing authorisations and safety evaluations. Emphasis was placed on post-authorisation measures and pharmacovigilance follow-ups for biological and biosimilar medicines. What This Means for You:Sponsors and MA Holders should…
The MHRA Inspectorate released an update reminding manufacturers and wholesalers about the renewal and recognition process for GMP and GDP certificates post-Brexit. What This Means for You:UK operations must verify certificate validity dates in parallel with EU renewals. QP and…
The FDA published a draft framework for assessing Artificial Intelligence and Machine Learning models used in drug and biological-product submissions. What This Means for You:If your company uses digital tools, data analytics, or AI in regulatory workflows, expect heightened scrutiny…
CMDh issued updated guidance covering the management of variations, national requirements, and harmonisation between mutual-recognition and decentralised procedures. What This Means for You:Regulatory teams preparing MRP/DCP submissions should ensure their variation procedures reflect CMDh’s latest recommendations. Include updated module 1…