Regulatory Affairs

March 9, 2021

A Quick Guide to Referencing an Approved Product for ANDA

Introduction A generic drug manufacturer refers to a reference listed drug (RLD) (an approved listed
March 8, 2021

Final Guidance on Competitive Generics Therapy (CGT): Opportunity to benefit from 180-day market exclusivity

March 8, 2021

Strengthening QPPV oversight through expert PSMF management for a global pharmaceutical company

APCER helped a leading generics company to streamline its PV related processes within 30 days.
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 ready documents and accelerated the
March 8, 2021

Efficiently navigating the regulatory submission landscape

The Regulatory Affairs team at APCER Life sciences helped the client with streamlining the XEVMPD
March 8, 2021

Inspection Readiness: Supporting the pharma company in ensuring regulatory compliance with highest standards

March 8, 2021

Streamlining lifecycle management through proficient eCTD submission roadmap

APCER’s Pharmacovigilance (PV) team provided PV services right from set up, training and database usage.
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 Management System (QMS) and successfully
March 8, 2021

Growing Generics Company Teams with APCER Life Sciences to File Marketing Authorization Applications without Delay

Our team of Regulatory experts helped a generic pharma company seek approval in the UK
February 18, 2021

Classification of cellular therapy and gene therapy (CGT) products: How regulators are working with industry

January 12, 2021

Importance of Engaging a Safety Partner Early in the Drug Life Cycle

Ms. Jeanne Schow, Vice President & US Head of Business Development talks the key benefits
January 10, 2021

Risk minimisation measures: Tracking and effectiveness assessment

January 8, 2021

Pharmaceutical Product Lifecycle Management: A Regulatory Consideration

January 6, 2021

RMP Team Collaboration Across Functions

January 6, 2021

aRMM Implementation Strategy

January 6, 2021

Regulatory Services

We offer end-to-end regulatory consulting and execution support services to bio-pharma companies to meet the
November 5, 2020

Human medicinal products containing nitrosamine impurities: Regulatory landscape in the United States and the European Union