Pharmalink Consulting provides regulatory affairs consulting services globally. It was founded in 1998 and has over 100 permanent staff and contractors. It helps clients with projects of all sizes, from small to large, domestic to multinational. Its clients include 18 of the top 20 healthcare companies. It has experience in Europe, North America, Latin America, Asia Pacific, the Middle East and Africa. It provides regulatory strategy, submissions, and interim staffing assistance. Case studies describe large product compliance projects, biosimilar submissions, and multinational clinical trials conducted for major pharmaceutical companies.

1. Pharmalink Consulting A Brief Overview

8. Pharmalink Consulting Case Studies

9. CLIENT: A major pharmaceutical company based in Europe PROJECT: A large product compliance project OBJECTIVE: Review all European-registered licenses and bring into compliance with current manufacturing site practices SOLUTION: Pharmalink provided a dedicated team of regulatory affairs specialists to work on the project for 3 years One of the key advantages that Pharmalink was able to bring to the project was the ability to adjust the number of consultants working on the project to fit the client’s needs and hit every deadline whilst always maintaining the level of quality CASE STUDY 1: Major regulatory compliance project

11. CLIENT: Major pharmaceutical company based in Europe PROJECT: Review and update of a Module 3 and Quality Overall Summary for a Biosimilar product in preparation for one of the first European submissions of its type OBJECTIVE: Document submission. Speed to market was of high priority to the client SOLUTION: Pharmalink was able to turn to one of its experienced consultants with a track record specifically with the biotech product in question Accurate review and submission preparation of the QOS and Module 3 The client could utilize the consultant's advice and make submissions according to the planned timeline CASE STUDY 2: Biosimilar product review

13. CASE STUDY 3: Multinational clinical trial sponsor & Clinical Research Organization CLIENT: Sponsor and CRO PROJECT: Provide regulatory support for a clinical trial including new submissions for the trial in multiple markets OBJECTIVE: Submit the clinical trial in multiple locations in a timely manner to allow trial initiation SOLUTION: Pharmalink provided consultants with valuable local knowledge to add to the regulatory intelligence of submissions in each market This project was a testament to the lengths to which the team went to understand the brief and work with the client to achieve their goals

20. Pharmalink Consulting Additional Information

23. What Clients say "The project was managed very efficiently by their office-based and on-site staff who are always quick to respond to our needs. We continue to use Pharmalink as our preferred source of consultants for long-term and short-term projects." Large Biotech Company "Many thanks to the Pharmalink project team for doing such a fantastic job. Our MA submissions were delivered very smoothly with impeccable timing." Virtual Pharmaceutical Company "Each of their staff members have been extremely helpful, efficient, and friendly and have always been willing to go the extra mile to meet our needs." Small Generics Company "...all projects have been delivered ahead of time or on time. Their experienced and professional approach is mirrored by the resource they supply." Large Generics Manufacturer