Confidence Beyond Compliance
Companies engaging in Merger and Acquisition (M&A) activities aim to gain momentum by undertaking one or a combination of the following to:
- Increase market share by consolidating their product portfolio into specific therapeutic areas
- Replenish their previously dwindling product pipeline
- Enter into emerging markets with existing and new products
- Reduce costs through the consolidation of manufacturing sites
In many cases, the decisions are made to satisfy shareholder’s and investor stakeholder’s expectations, who are eager to see more immediate business results. However, it is crucial to reflect on the various divisions that must be integrated in this process and be aware that M&A activities bring along tasks that lie outside the scope of the usual everyday business. Additionally many fail to see some of the pitfalls that come with these decisions and to what degree this affects the regulatory affairs department.
PharmaLex is able to leverage their extensive experience working on M&A related RA activities on both a European and worldwide level across multiple client programs to tackle these hurdles and allow current or prospective clients to achieve their corporate goals in a compliant and timely manner.
What our clients say
During the bid defense we felt that you worked well as team and are very dynamic. Preparation of such a complex dossier really needs to be done in such a way.
VP Regulatory Affairs
Worked with us and our contractors to help us achieve our tight targets, operate with our systems and procedures and are considered invaluable part of our team
VP Regulatory / Quality