Compliance and peace of mind from concept to market

The constant tightening of global regulatory requirements makes it increasingly complex to develop healthcare products and bring them to market.


We support start-ups, biotechs, and laboratories at every stage, from pharmaceutical development to the preparation and submission of registration documents (CTD/eCTD), as well as technical support for interactions with competent authorities (EMA, FDA, ANSM, etc.).

Integrated regulatory support for your projects

Regulatory support is an integral part of every development project.

Obtaining regulatory approval is an essential condition for a product’s success. We systematically provide:

A dedicated regulatory expert, involved from project inception

Proactive support: asking the right questions and anticipate requirements

A final review of your documents, before official submission.

Customizable services

Depending on your project and internal resources, we also offer a range of customizable services.

We offer these services to ensure the safe and timely market entry of your products.

Strategic advice

in-depth (targeted markets, registration pathways)

Preparation of CMC documentation

required for MA

Drafting of documents

for clinical trial requests (IMPD (Europe)/ IND (United States)) for the pharmaceutical section

Drafting and preparing

full technical documentation for medical devices

Managing responses

to questions from authorities

Support

for new submissions or renewals

Regulatory Support

during major variations and audits

Why choose Unither's integrated regulatory support?

Save time and reduce risks: thanks to in-depth expertise in international guidelines

Ensure compliance at every stage: from design to product lifecycle

Reduce the number of contacts: a single partner, a single contract, a global vision

FAQ - Regulatory support

CMC regulatory support ensures your product and processes remain compliant with health authority requirements (EMA, FDA, ANVISA, etc.) throughout their lifecycle. At Unither, this support is provided by a dedicated regulatory affairs team within the Development, Quality, and Production teams. The service ensures the drafting and submission of dossiers (IMPD/IND, CTD/eCTD) goes smoothly, facilitates communication with authorities, and assists with post-authorization stages: variations, renewals, and audits.

Our regulatory support covers all product categories developed or manufactured at our sites:

 

  • Medicinal products: new chemical drugs, generics/hybrids, orphan drugs, prescription-only or OTC products according to local guidelines (EMA, FDA, etc.), etc.
  • Medical devices: CE-certified (in accordance with MDR regulation 207/745) or intended for registration outside Europe based on CE marking.
  • Other health products: food supplements or other products, as applicable.

 

Each project benefits from tailored support adapted to the regulatory frameworks of the target markets.

Yes. Certain regulatory support is always included during development and manufacturing projects. In some cases, we also offer additional regulatory services:

  • Registration strategy,
  • Full preparation of CMC modules (IMPD/IND, CTD/eCTD)
  • Variation management and inspection support.

Yes. Our regulatory team can assist with variation management, compliance updates, and post-marketing surveillance, but only for products manufactured at our own sites.