Pharmaceuticals · Medical Devices · Food Supplements · Cosmetics

Regulatory affairs consulting,
handled.

AML Global Partners provides regulatory affairs consulting services for pharmaceuticals, medical devices, food supplements and cosmetics in the EU, the United States, the GCC and other international markets, without the delays and overhead of a large consultancy.

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What we manage for you
Your compliance, fully covered
Regulatory Affairs FDA, EU, ECHA submissions
Market Adaptation Labels, formulas & import rules
Quality & Safety SDS drafting & quality assurance
GMP · ISO 22716 · REACH
◆AEMPS ◆AESAN ◆EMA ◆EU MDR 2017/745 ◆EUDAMED / RECOPS ◆CPNP ◆EFSA ◆REACH / CLP ◆GMP ◆ISO 13485 ◆ISO 22716 ◆FDA
What we do

Regulatory affairs
consulting services

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From the first regulatory strategy to market authorisation and post-market obligations, we act as your regulatory affairs team: we prepare the dossiers, deal with the competent authorities of each market (from the EMA, ECHA and national agencies to the FDA and GCC regulators) and keep your products compliant once they are on the market.

01

Pharmaceutical regulatory affairs

Medicinal product registration with the EMA and AEMPS, CTD/eCTD dossiers, lifecycle variations and GMP compliance consulting.

 02

Medical device regulatory consulting

CE marking under EU MDR 2017/745, technical documentation, EU Authorised Representative and AEMPS registration in RECOPS.

 03

Food supplement regulatory consulting

AESAN and EU notifications, label and health claims review, and novel food assessments across multiple countries.

 04

Cosmetics regulatory consulting

CPNP notification, safety assessment, PIF preparation and EU Responsible Person services under Regulation (EC) No 1223/2009.

 05

REACH and chemical compliance

REACH registration, CLP classification, safety data sheets and UFI notification with ECHA.

 06

Laboratory testing

Stability, challenge and efficacy testing through accredited laboratories, with data ready for your regulatory submission.
How we work

Your outsourced
regulatory affairs team

1. Regulatory assessment

We review your product, its classification and your target markets, and define the fastest compliant route to market with a clear timeline.

2. Dossier and submission

We prepare the technical documentation, submit it to the competent authorities and handle their questions until the product is authorised or notified.

3. Ongoing compliance

After launch we manage variations, renewals, vigilance and regulatory changes, either per project or as your outsourced regulatory affairs function.

Why AML

Science first.
Compliance always.

Senior experts, direct access

You work with the specialists, not account managers. Every engagement is handled by regulatory scientists and chemists who know your regulatory framework inside out.

Faster turnarounds

We run lean by design. Without the layers of a large consultancy, we move faster.

40+ markets

We hold active regulatory experience across the EU, US, GCC and Asian markets, including territories most consultancies rarely cover.

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FAQ

Regulatory affairs consulting:
frequently asked questions

What does a regulatory affairs consultancy do?

A regulatory affairs consultancy helps manufacturers place products on the market legally. It defines the regulatory strategy, prepares the technical dossiers, submits them to the competent authorities (such as the EMA, the FDA or national agencies) and keeps products compliant after launch through variations, renewals and vigilance.

Which products do you cover?

Medicinal products, medical devices and in vitro diagnostics, food supplements, cosmetics and chemicals under REACH and CLP. See our regulatory affairs services by sector.

Which markets do you work in?

We work internationally: the European Union, the United Kingdom, the United States (FDA), the GCC countries and other markets in Asia. Each authority has its own rules, so we coordinate the requirements of every market in parallel to keep your launch dates aligned.

Can you act as our outsourced regulatory affairs department?

Yes. Besides one-off projects, such as a registration, a notification or a dossier, we can take on your regulatory affairs function on an ongoing basis, so you do not need to build an in-house team.

When should I hire a regulatory affairs consultant?

Ideally before development is closed: classification, formulation and labelling decisions made early avoid reformulations and delays later. It also makes sense when entering a new market, when regulations change (as with EU MDR) or when your team lacks capacity.

Know your market.
We know the path.

Tell us your product and target markets. We will identify your fastest, cleanest route to compliance and start working on it immediately.

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