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Regulatory Affairs
March 9, 2021
March 9, 2021
Classification of cellular therapy and gene therapy (CGT) products: How regulators are working with industry
March 9, 2021
March 9, 2021
A Quick Guide to Referencing an Approved Product for ANDA
March 8, 2021
March 8, 2021
Final Guidance on Competitive Generics Therapy (CGT): Opportunity to benefit from 180-day market exclusivity
March 8, 2021
March 8, 2021
Enabling compliance through strong PSMF management & QPPV oversight
APCER helped a leading generics company to streamline its PV
…
March 8, 2021
March 8, 2021
Accelerating product approval by handling complex and voluminous medical writing projects
Our Medical Writing team helped the client in handling e-submission
…
March 8, 2021
March 8, 2021
Efficiently navigating the regulatory submission landscape
The Regulatory Affairs team at APCER Life sciences helped the
…
March 8, 2021
March 8, 2021
Inspection Readiness: Supporting the pharma company in ensuring regulatory compliance with highest standards
Read how our Quality Assurance team helped a pharma company
…
March 8, 2021
March 8, 2021
Streamlining lifecycle management through proficient eCTD submission roadmap
APCER’s Pharmacovigilance (PV) team provided PV services right from set
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March 8, 2021
March 8, 2021
GCP Audits in EU requiring local language competency for a biopharma company
We helped a biopharma company to set up end-to-end Quality
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January 12, 2021
January 12, 2021
Importance of Engaging a Safety Partner Early in the Drug Life Cycle
Ms. Jeanne Schow, Vice President & US Head of Business
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January 10, 2021
January 10, 2021
Risk minimisation measures: Tracking and effectiveness assessment
January 8, 2021
January 8, 2021
Pharmaceutical Product Lifecycle Management: A Regulatory Consideration
January 6, 2021
January 6, 2021
RMP Team Collaboration Across Functions
January 6, 2021
January 6, 2021
aRMM Implementation Strategy
January 6, 2021
January 6, 2021
Regulatory Affairs Services
We offer end-to-end regulatory consulting and execution support services to
…
November 5, 2020
November 5, 2020
Human medicinal products containing nitrosamine impurities: Regulatory landscape in the United States and the European Union
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