Insights
April 5, 2024
A leading device manufacturer faced challenges complying with complex device regulations and thus struggled to …
February 19, 2024
January 11, 2024
September 21, 2023
Medical device companies would need robust and effective strategies to comply with the ever-changing regulatory …
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 …
February 22, 2023
December 6, 2022
With the ever-growing knowledge of science and application of advanced technology, new and sophisticated medical …
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 …
August 5, 2022
Ms. Shellie Cholke, Vice President – Sales talks about three key success factors to help …
June 20, 2022
APCER Life Sciences provides the right expertise and support required for coping up the ever-dynamic …
June 16, 2022
Our Integrated Pharmacovigilance operating model offers choice of best-in-class databases coupled with in-house scientific expertise …
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 …
April 26, 2021
Key Regulations & Guidelines: Medical Device Reporting – 21 CFR Part 803 Guidance on Medical …
April 23, 2021
Rapidly changing regulations in the European Union are making regulatory compliance even more stringent. As …
April 23, 2021
The EU and UK regions have stringent Pharmacovigilance and regulatory requirements such as electronic and …
April 5, 2021
March 9, 2021
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
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 …
January 13, 2021
Mr. Tejus Menon, Executive Director shares his perspective on what will companies do in the …
January 12, 2021
Ms. Jeanne Schow, Vice President & US Head of Business Development talks the key benefits …
January 10, 2021
Our team of experienced auditors help the bio-pharma companies achieve process excellence and regulatory compliance. …
January 10, 2021
Our team of efficient and experienced medical writers support the biopharma companies in delivering high …
January 10, 2021
APCER Life Sciences provides the expertise and support required for coping up the ever-dynamic global …
January 10, 2021
APCER Life Sciences provides the expertise, robust processes and infrastructure required for global pharmacovigilance. Our …
January 10, 2021
APCER Life Sciences works together with your team and research partners to create a centralized …
January 6, 2021
APCER Life Sciences provides 24×7 fully customizable, multi-channel and multi-lingual Medical Information services to biopharma …
January 6, 2021
We offer end-to-end regulatory consulting and execution support services to bio-pharma companies to meet the …
January 6, 2021
Snapshot of end-to-end Safety services offered by APCER Life Sciences. We provide comprehensive drug safety/pharmacovigilance, …
December 11, 2020
Dr. Vineet Kacker, Managing Director & Global Technical Head talks about the how Advanced Therapy …
November 5, 2020
