Health Authority Regulatory Liaison and Legal Representation
Your Local Representative for In-Country Requirements and Marketing Authorization Holder with proven Experience in Ensuring Safety, Compliance and Successfully Managing HA Relations
Services We Offer
Authorized Local Representation Across Regions
Artixio’s presence in 120+ countries worldwide through its direct offices and local regulatory associates positions it to act as your trusted partner for your lifesciences products roll out and act as Marketing Authorization Holder in markets of your strategic interest. Artixio’s local teams have 15-35 years of experience in managing Health Authority relations, navigating regulations and legislations for complex new drugs, biologics, biosimilars, medical devices, generics, diagnostics, cosmetics, nutraceuticals, food supplements and animal health, veterinary products.
Once you partner with Artixio as your appointed authorized agent or local legal representative in a country, Artixio will represent you to the Health Authority and be responsible for your products’ safety and compliance. Our support encompasses regular HA meetings, interactions to assist consultations, pre-submission strategy, dossier submission and post approval maintenance of license as per regional laws and legal requirements.
Our Approach to Health Authority Communication
Benefits of Partnering with Artixio For HA Legal Liaison
- Local experts who know how to work with health authorities — clearly and confidently.
- Proven Experience in Successful Registrations
- HA / Trade Associations / Industry Network to Keep Track of Regulatory Changes
- Fully Compliant with Local Licenses to Represent International Manufacturers Locally
- GDP Compliant Warehouses where required
- Highly Qualified Experts for Regulatory, Pharmacovigilance, Medical Affairs
- End to End support across Registration, GMP/GDP, Import, Custom Clearance, Distributors Management, Clinical Trials, Testing and other logistics support
- Regulatory Intelligence Platform: Tech-Enabled Regional Insights based on Regulations, Laws and Experience
- Global Best Practices to Regional Success
FAQS
What is the Role of a Legal Representative for Regulatory Affairs?
Most of the countries’ regulations require international companies to be represented by a local agent to be responsible for products’ safety in the country. A legal representative is a person and/or entity who is authorized by international manufacturers of pharmaceutical, medical devices, cosmetic or nutraceutical products to represent them in country, locally. This is a requirements as per many countries’ regulations, legislations and laws. The Legal Representative’s role includes Local Representation to the Health Authority (such as US FDA, EMA, MHRA, CDSCO, TGA, HSA, NMPA, NPRA etc.), responsible for products’ safety, respond to HA queries, managing the product compliance from submission of dossier to lifecycle submissions and assist with import and custom clearance.
What are some others terms used for Legal Representative?
Often different countries refer to different names/ terminologies for legal representation with more or less similar responsibilities. However, the objective of Health Authorities remains to ensure a local person/agent who is responsible for the safety of the products marketed in the country. Some of the terminologies include, Responsible Person, Local Agent, Local Representative, Authorized Agent, In-Country Caretaker, Local Sponsor etc.
What are the requirements for a Local Representative?
A local representative in most countries must have,
- Qualified person with educational qualification or experience in pharmaceutical or related lifesciences industry (usually a pharmacist with license)
- Locally registered business to act as MAH or legal representative
- Necessary Manufacturing / Wholesale / Retail license for pharma, medical devices, food, cosmetic products
- A warehouse with cold storage as per local regulatory legal requirements and specifications
- GDP compliance warehouse is required in some countries where audits are conducted by the HA
- Import Export License for facilitation of imports
- Accounts or Access to Online Submission portals (such as PRISM in Singapore, SUGAM in India etc.)
- Valid country identity numbers or cards (CorpPass, Aadhar etc.)
What challenges do international companies face working with local representatives?
Often international manufacturers face challenges in finding right local representatives. Some of the challenges include.
- Finding a qualified person with required technical expertise and experience with regulations
- Understanding of global standards, approach and ability to bridge with local requirements for technical requirements, communication, project management etc.
- Communication (both spoken and written) proficiency in both English and Local language
- Lack of transparency
- Experience and size of team for managing multiple activities
- Lack of planning and proactively solving problems that could arise locally, often reactive way of working leading to issues and non-compliance
- Lack of defined processes, issues with data security and intellectual property safety
How do you Support Legal Representation / HA Liaison in different countries?
Artixio has local offices and team members in different countries. In addition, we extend our support to other countries working with our long-term regional regulatory experts who are qualified to act as local representatives. We are currently representing over 5000 products in global markets across Asia, Latam, Europe and North America where products include new drugs, generics, biologics, biosimilars, cosmetics, nutraceuticals, food supplements and animal health. In all these countries, we leverage Artixio and our experts local presence, regional licenses, warehouse, industry network, HA experience and internal regulatory project delivery excellence to support our clients seamlessly.
Still Have Questions ?
Specialized Regulatory Services Across Multiple Industries
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
Expert Regulatory Services To Streamline Compliance
Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Regulatory Services Across Multiple Countries
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
European
Thailand
Indonesia
Philippines
USA
Japan
Qatar
South Korea
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