Quality Assurance Services: Continuous Compliance, Total Confidence
Inspection Ready. Audit Ready. Quality Assured.
In today’s regulatory environment , quality is not just a requirement. It underpins trust, ensures compliance with regulatory expectations, and strengthens overall inspection readiness and business continuity.
At APCER, our Quality Assurance solutions are designed to keep your systems compliant, your processes controlled, and your organization prepared at all times. We support pharmaceutical, biotech and medical device companies with comprehensive QA oversight across the drug development lifecycle.
Our experienced team combines global regulatory expertise with agile methodologies, validated systems, and a robust eQMS framework to identify risks early, strengthen controls, and maintain continuous inspection readiness. You focus on innovation and growth and we'll make sure quality stands up to scrutiny. At APCER, quality is not just a habit, it is a commitment.
Quality Assurance Expertise Across Every Risk and Every Requirement
From proactive risk management to continuous inspection readiness, APCER delivers integrated Quality Assurance solutions that strengthen compliance.
Risk-Based Audit Programs – Focus Where Risk Matters Most
Our customized, risk-based audit programmes use structured risk evaluation to identify, plan and conduct risk-based audits in line with regulatory expectations. We conduct comprehensive GVP and GCP audits across end-to-end pharmacovigilance and clinical systems globally, covering affiliates, business partners, service providers, CROs, clinical sites, TMFs, electronic systems, and complex product portfolios including biologics.
Inspection Readiness & CAPA Management – Always Prepared
We prepare and support your organization for regulatory inspections through mock audits, gap assessments, targeted training, document reviews and realtime inspection support. Our structured CAPA framework ensures effective closure of findings and sustained compliance. With our Anytime Inspection Readiness (AIR) approach, you stay inspection prepared year-round.
Quality Management Systems – Build Compliance into Operations
We streamline QMS setup by creating clear, applicable SOPs and policies, supported by structured processes for change control, deviations, CAPAs, training, and document management. We also ensure comprehensive review of Pharmacovigilance documentation, including PSMFs and PV agreements, to maintain consistent compliance. We help you stay compliant to GVP/GCP requirements and stay aligned with all the global standards.
Built on Standards.
Proven Under Inspection .
IRCA
ISO
Trusted Quality Assurance for High‑Risk Responsibilities
Ready for a partner who matches your ambition?
With APCER, you gain more than a service provider—you secure a champion for compliance, a catalyst for growth, and a steadfast ally dedicated to protecting patients and your reputation.
Meet Our Experts
Pradeep Manglani
M.Sc. (Microbiology)
Vice President - Global Quality and Compliance
Apoorv Sharma
B.E., MBA
General Manager - ISMS
Real Results. Real Trust.
Real Stories
Sincerely thank you for all the effort, thoroughness and professionalism that went through conducting and reporting on this FDA PADER Gap Analysis as we now embark on our journey towards documentation and process improvement to ensure readiness for an actual inspection.
Director, Drug Safety and Medical Information
Canada-based global pharma
The APCER Pharmacovigilance team demonstrated exceptional collaboration and inspection readiness during FDA PADE Inspection. The accuracy, consistency, and completeness of expedited reports, reconciliations, and aggregate safety documentation clearly reflected strong teamwork and compliance across all deliverables.
VP, Regulatory and Quality
US-based biopharma
With all the transformation and rapid growth happening, having a reliable PV/med info partner like the APCER group has truly been invaluable—it’s made a real difference in helping us navigate the complexities and keep challenges to a minimum.
VP, Medical Affairs
US-based specialty pharma
... the preparation and support for our BPD Type 2a meeting were a strong example of APCER’s commitment and effectiveness and instrumental in keeping us aligned and confident in our regulatory strategy. We have greatly valued the team’s responsiveness, collaborative approach, and sound regulatory judgment.
Chief Medical Officer
A clinical-stage biopharma
Phase 1 completion is an achievement that demonstrates APCER's scalability, flexibility, and operational readiness. It reflects exceptional cross-functional collaboration.
Associate Director, IT Business Partner
Japan-headquartered, global healthcare company
I want to sincerely appreciate all the great work Team APCER has been doing. Their strong attention to detail, agility in handling tasks, and consistent respect for timelines have been truly impressive.
Associate Director, Safety Physician
Japan-headquartered, global healthcare company
Deep gratitude to entire APCER team for their efforts in working hard to complete the cases. While the system outage was well beyond their control, their strong work to make up for the lost time ensured that we're able to maintain compliance.
Associate Director, Pharmacovigilance Operations
US-based biotech
Sincere appreciation for APCER's partnership and dedicated service. The team’s commitment, adaptability, and collaborative approach have been instrumental in supporting our pharmacovigilance operations through both high and low volumes of activity.
Sr.Director, PV Operations-Global Case Management
US-based biotech
I’ve greatly valued APCER’s commitment to excellence. Their contributions have played a key role in helping us uphold our compliance standards and achieve strong performance across key metrics, including timely deviation closure, audit readiness, and quality of deliverables.
Sr. Director PV Ops – Pharmacovigilance Center of Excellence
US-based biotech
