Case Studies
April 5, 2024
A leading device manufacturer faced challenges complying with complex device regulations and thus struggled to …
May 3, 2023
CMC writing is a standardized scientific and technical writing process to develop the documentation needed …
March 6, 2023
A drug product transitions from different phases throughout its life cycle. The sponsors/applicants may outsource …
September 30, 2022
Managing Medical information (MI) services in-house is a major challenge for any pharmaceutical company. Read …
September 2, 2022
Our Medical Writing team helped the client in updating and submitting high-quality investigator brochure- a …
May 18, 2022
We supported a large biopharma company in preparing manuscript/narrative review articles and leveraged our Medical …
April 21, 2022
APCER life sciences through its oncology expertise helped the pharma company manage its pharmacovigilance activites …
March 8, 2021
APCER’s Pharmacovigilance (PV) team supported a client’s expansion into new markets by setting up a …
March 8, 2021
APCER’s Pharmacovigilance (PV) team helped a biotech pharmaceutical company with set up, training and database …
March 8, 2021
APCER helped a leading generics company to streamline its PV related processes within 30 days. …
March 8, 2021
We helped a large pharmaceutical company successfully transition its pharmacovigilance (PV) processes and helped establish …
March 8, 2021
Our Medical Writing team helped the client in handling e-submission ready documents and accelerated the …
March 8, 2021
APCER helped a global pharmaceutical company in establishing a collaborative global pharmacovigilance (PV) governance model; …
March 8, 2021
APCER Life Sciences supported one of the biopharma companies in assessing the effectiveness and setting …
March 8, 2021
APCER Life Sciences supported a leading generic pharma company with managing the EU RMP requirements …
March 8, 2021
The Regulatory Affairs team at APCER Life sciences helped the client with streamlining the XEVMPD …
March 8, 2021
Read how our Quality Assurance team helped a pharma company successfully host the USFDA inspection …
March 8, 2021
APCER’s Pharmacovigilance (PV) team provided PV services right from set up, training and database usage. …
March 8, 2021
We helped a biopharma company to set up end-to-end Quality Management System (QMS) and successfully …
March 8, 2021
APCER Life Sciences helped develop the strategy and provided medical monitoring services that accelerated the …
March 8, 2021
Our medical monitoring team with experience and expertise in early clinical development stages provided oversight …