Strategy and planning of product development from discovery to production.
Low cost API sourcing for generic products and technology transfer of all types including API and pharmaceutical products.
Regulatory affairs - your fast track to market
e-CTD submissions - Development, preparation, assembly and submission of complete electronic Common Technical Documentation (e-CTD) for marketing authorization applications (MAAs) in both Europe and the USA.
Auditing services - Data integrity auditing
The aim of the audit is to identify and reduce high-risk areas within a dataset to prevent data integrity breaches.
Legal services - expert witness and due diligence
We are often called upon to act as expert witnesses, providing advice and guidance on the resolution of legal disputes. We also undertake due diligence on product and portfolio purchases for a number of multinational companies.
Quality services - Data integrity auditing in manufacturing and product development.
Helping you reduce high-risk areas within a dataset to prevent data integrity breaches.
e-CTD submission service to pharmaceutical manufacturers and consultancies.
This is a cost-effective solution for businesses who want to save time and money.
Submission of complete electronic Common Technical Documentation (e-CTD) for marketing authorization applications (MAAs)
Quality assurance and compliance consulting in the pharmaceutical industry
Providing advice and guidance on the resolution of legal disputes
What our clients say about us
“Their unique expertise opened up new possibilities and ideas, saving us time and money while improving our product development success rate.”
“We required development and implementation of a Quality Management System in order to operate to GMP. PDS designed and implemented a system to suit size, structure, operations and culture of company. They appointed an interim QA Manager to oversee project. He then stayed with us throughout the implementation to ensure system worked as planned.”
“We needed a supplier audit programme as part of our licence application. PDS analysed our problem and designed a programme of audits, rapidly assessing high risk suppliers and establishing a robust schedule enabling us to gain control in a short period of time. Audits were carried out by PDS consultants to a high standard. Their documentation also provided a basis for our ongoing supplier management plan.”