Business and Portfolio Mergers & Acquisitions
Achieve your business goals in a compliant and timely manner with our Merger & Acquisition support
Merger and Acquistion (M&A) decisions are often made to satisfy shareholder and investor expectations for quick business results. However, adopting a narrow approach to M&A can be costly. A successful strategy must ensure different stakeholders are brought into the M&A process early on, and that functions that lie outside the scope of typical business activities have a seat at the table. Making M&A decisions without considering key functions, such as regulatory affairs, can have a detrimental effect on these departments and on the overall agreement.
Companies engaging in 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 product pipeline
- Enter emerging markets with existing and new products
- Reduce costs through the consolidation of manufacturing sites
Successfully achieving these goals requires a holistic approach that brings together the knowledge of different parts of the organization.
Our trusted team
The expert team at PharmaLex leverages their extensive experience working on M&A-related regulatory affairs activities globally and across multiple client programs to tackle these hurdles. Their knowledge and insights enable current and prospective clients to achieve their corporate goals in a compliant and timely manner.
CMC strategy and documentation plays an important role from early development to authoring of the marketing authorization application dossier. It also extends to change control and maintenance throughout the product lifecycle. Moreover, CMC requirements are complex and different for chemicals, biologicals, biosimilars, herbals or homeopathics. PharmaLex guides you to the best CMC approach for your products in line with health authority requirements and helps you to stay CMC compliant with sustainable processes.More Info
eCTD, System Operations and Data Management
Ensuring a smooth and effective submission process today goes beyond the old ways of eCTD publishing. For over 15 years, we have led the way in regulatory submissions with an evolving holistic approach that includes everything from planning to embedded quality control. Of course, all of our services are complemented by state-of-the-art digital facilitation.More Info
Gap Analysis and Consulting
Place your Pharmacovigilance, Epidemiology, Risk management (PER) and Document Management activities in experienced hands. Whether you need an urgent solution for an unexpected problem or are seeking to outsource entire processes – our knowledgeable experts will be there for you no matter where you are. Expertise extends to Clinical document management (e.g. TMFs) and Regulatory document management (e.g. submissions, RIM, xEVMPD, IDMP) through one of the PharmaLex family of companies.More Info
Ensuring your internal systems, or those of your supplier or client meet the necessary requirements, is essential before undertaking any regulatory process. It is also pertinent to follow good practice (GxP) guidelines in order to satisfy the regulators that all aspects meet their standards.More Info
GxP Technical Consulting
Our GxP Technical Consulting Service provides access to our international Consulting Team, including a number of former EU and US Regulators, with expertise across the entire product lifecycle, ensuring that the broad Regulatory perspective is factored into the detailed consideration of your queryMore Info
PharmaLex’s organization ensures global delivery of all PV audit services. We are the first-choice provider of PV audit services for many pharmaceutical companies around the world. At PharmaLex, auditors are highly qualified with necessary and long-standing expierence as well as strong cultural awareness and excellent communication skills to effectively conduct and/or participate in PV audit activities.More Info
Quality Systems and Compliance
PharmaLex can provide support with PQS planning, development and implementation. We can also remediate PQS that are not working properly and we can also provide support with the implementation or remediation of specific elements of the PQS such as Supplier management, Quality Risk Management, Change Management, Learning Management and deviation management to name a few. We can design and implement PQS for MIA, WDA and MAH.More Info
Regulatory Writing / Scientific and Technical Writing
PharmaLex offers scientific, regulatory and technical writing, supporting clients in the development of medicinal products.More Info
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