Regulatory affairs support and services

Partner with us and benefit from our regulatory expertise to support your product's journey from development to market and provide a painless experience making us the preferred service provider for your business across all global regions.

How we support you

We understand the complexities of navigating regulatory requirements in the pharmaceutical and biotechnology industries, especially across multiple jurisdictions. Our strong focus on global regulatory support ensures pharmaceutical producers meet all national and international requirements.
With dedicated global and local teams, we provide ongoing monitoring, compliance management, and impact assessments to navigate the ever-evolving global regulatory landscape.
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End to end regulatory expertise at your service

You have plenty of options to choose from, meaning the level of our involvement and coverage of your product life cycle can be tailored precisely to your needs. We achieve this by cultivating close relationships with producers around the world, enabling us to offer regulatory support which meets your needs. Our services cover the sourcing of products, supplier assessment and supply chain evaluation.
We have established relationships with emerging markets, conducting audits and supply chain evaluation throughout the regions. This ensures we source high quality raw materials which are available globally and compliant with all existing, as well as upcoming, regulatory developments.
We have a stringent supplier approval process to ensure that our product portfolios are approved in accordance with the applicable standards. That includes:
  • APIs
  • Excipients
  • Biopharma
  • Starting Materials

Knowledge built on strong foundations

As an industry leader and full-service solutions provider, we are building our offer on two main pillars, combining them together to streamline the entire process and bring clarity and compliance, helping you remain compliant to all of your legal entities.
Regulatory and technical support
We evaluate a wide range of products globally ensuring they meet a range of appropriate pharmacopeias to guarantee suitability in the desired country.
Documentations and quality agreements
We review and obtain documentation and quality agreements worldwide, ensuring they meet regulatory expectations and align with the specific requirements of each market.

Quality Standards

With more than 700 sites worldwide, our expertise is backed by industry-leading standards and guidelines including IPEC, GMP, GDP, ISO9001, ISO14001, GFSI and HACCP. Proven time and again, we are the trusted partner of choice for quality, safety and reliability.
We also operate GDP registered sites to support the distribution of Active Pharmaceutical Ingredients.

Contact us

We invite you to contact us for all your needs regarding compliance and regulatory affairs. Benefit from our expertise. commitment to excellence and unwavering support. Contact us today to find out what support we can provide in your region or to let us know what we can do for you.