We facilitate the registration of your pharmaceutical products in target markets worldwide, ensuring compliance with local regulatory requirements.
Essential documentation for market approval and compliance:
Internationally recognized proof that your manufacturing facility meets WHO or other stringent GMP standards.
Certifies that your products are legally marketed in the country of origin, required for many export markets.
Mandatory for WHO-listed countries, confirming product quality and regulatory status.
Official proof of your business registration in the United Kingdom, with certified translations available.
End-to-end support for document preparation and validation:
Accurate translation of all documents (e.g., GMP, FSC, COPP, company registration) into the target country’s official language.
Legalization of documents through the respective country’s embassy or consulate in your factory’s location for international validity.
Customized document sets tailored to the regulatory requirements of each target market (e.g., FDA, EMA, GCC, ASEAN).
Expedited handling to meet urgent deadlines without compromising compliance.
Assistance with queries from health authorities and additional documentation requests.
Answers to your regulatory registration and approval questions
We cover all major markets including EU member states, GCC countries, ASEAN nations, African markets, and Latin America, with country-specific requirements for each region.
Initial certification requires 3-6 months, while renewals are faster (1-2 months). We expedite the process through direct contacts with certifying bodies.
A Free Sale Certificate (FSC) confirms your product is legally marketed in its origin country. A Certificate of Pharmaceutical Product (COPP) includes quality and manufacturing data required by WHO-participating countries.
Yes, most regulatory authorities require separate registrations for each strength and formulation as they consider them distinct products.
Yes, we offer expedited processing that can reduce standard timelines by 30-50% through priority document handling and direct regulator liaison.
Answers about document preparation and authentication
GMP certificates, Free Sale Certificates, and company registration documents typically need embassy attestation for most Middle Eastern and African markets.
All UN languages plus key market languages (Arabic, Chinese, Russian, etc.), translated by certified pharmaceutical linguists with QA by regulatory experts.
Standard processing takes 7-15 business days. Express services (3-5 days) are available at most embassies for additional fees.
Our regulatory team immediately assesses alternatives (like interim reports) or prepares missing documents, with most requests resolved within 5 business days.
Yes, we provide complete renewal services including document updates, regulatory correspondence, and fee payments to maintain your market authorizations.