Test Reports and Authorisation Letters Online: HaoYang Biotechnology Signs Across Borders

Company Introduction

Hangzhou HaoYang Biotechnology Co., Ltd. provides customers with antibody, fusion protein and ADC products. It offers one-stop research and production services covering early druggability evaluation, IND research and commercial production, and operates from a base in China while serving clients globally.

Because its clients are often abroad, the company’s documentation crosses borders regularly. Test reports and authorisation letters are part of the working relationship between HaoYang’s operations in China and partners involved in gene testing and pharmaceutical development, which makes the company a useful reference for research organisations signing regulated documents internationally.

Business Challenges

1. Test reports and authorisation letters had to be signed by overseas individuals

HaoYang Biotechnology initiates the signing of documents such as test reports and authorisation letters by overseas individuals for cooperation in gene testing and pharmaceutical development. The company is the initiating party in China, while the signer may be an individual abroad.

These documents are not incidental. A test report or an authorisation letter is part of how the company and its partners establish what has been tested, what has been authorised and what can proceed. When signing depends on international mail, that step adds delay to work that is often sequenced against research timelines.

2. Documents supported cooperation in two different directions

The documents support cooperation both domestically and abroad. That means the same document types serve partners in different jurisdictions with different expectations, and the company has to produce signed paperwork that works for both.

Handling this with paper creates a practical inconsistency: domestic signers and overseas signers inevitably complete documents at different speeds, which makes the overall cooperation schedule harder to plan.

3. Research timelines were sensitive to documentation delay

Pharmaceutical development runs on sequenced milestones, from early druggability evaluation through IND research to commercial production. Each stage depends on the previous one being confirmed, and the documents that authorise a stage are part of that chain.

If a test report or authorisation letter is waiting on international mail, the delay is not just administrative. It sits on a critical path where the next stage of work may depend on the document being signed.

Solution & Results

1. Test reports and authorisation letters signed online

With eSign.AI, HaoYang Biotechnology initiates the signing of test reports and authorisation letters by overseas individuals through an electronic process. Documents are sent for signature online rather than printed, posted and returned.

This removes the transit step from documents that authorise cooperation in gene testing and pharmaceutical development. The company can initiate a signature and have it completed on a working-day timescale rather than a postal one.

2. One process for domestic and overseas signers

The company signs these documents through the same electronic process whether the signer is based domestically or overseas. Because the process is uniform, the company does not maintain separate habits for different jurisdictions, and the signing step no longer behaves differently depending on where the signer happens to be.

For a company serving global clients from a base in China, that consistency makes the cooperation schedule easier to plan, because signing no longer introduces a jurisdiction-dependent variable.

3. Documentation that keeps up with research milestones

Bringing authorisation documents online means the signing step can be planned against research milestones rather than run behind them. Documents that confirm a stage or authorise the next one can be completed closer to the point they are needed.

For a company working across early evaluation, IND research and commercial production, keeping documentation aligned with research timelines supports the overall ability to sequence work predictably.

Application Impact

HaoYang Biotechnology moved test report and authorisation letter signing online, so documents involving overseas individuals no longer depend on international mail.

Domestic and overseas signers now complete these documents through the same electronic process, which removes the inconsistency that arises when different jurisdictions run at different paper speeds.

For a biopharmaceutical company providing antibody, fusion protein and ADC services from China to global clients, the outcome is documentation that keeps pace with research milestones, so the signing step supports the development schedule rather than delaying it.

Related Reading

• Life Sciences Compliant eSignature Solution Guide — How life sciences organisations structure electronic signing across regulated research and production documents.
• FDA 21 CFR Part 11 Electronic Signatures — The US regulatory framework for electronic records and signatures in regulated life sciences work.
• Best eSignature Providers for Regulated Industries — Evaluation criteria for organisations whose documents are subject to regulatory expectations.