Formal Letter of Engagement (LOE) and Master Services Agreement (MSA) - HSA Licence & GDP Support
- Roger Pay
- 1 day ago
- 7 min read
Formal Letter of Engagement (LOE) and Master Services Agreement (MSA) - HSA Licence & GDP Support
LETTER OF ENGAGEMENT & MASTER SERVICES AGREEMENT
Date: 21 August 202[X]
To:
[XYZ Pte. Ltd.]
Attn: [Abc, Director]
Email: abc.d@xyz.com
Dear Eason,
RE: LETTER OF ENGAGEMENT AND MASTER SERVICES AGREEMENT FOR HSA IMPORTER & WHOLESALER LICENCE APPLICATION SUPPORT & GDP COMPLIANCE SETUP
We are pleased to present this Letter of Engagement ("LOE") and Master Services Agreement ("MSA") to act as professional advisor to [XXX Pte. Ltd.] ("Client") in connection with your application for the Health Sciences Authority ("HSA") Therapeutic Products Importer's Licence ("TPIL") and Wholesaler's Licence ("TPWL"), Good Distribution Practice ("GDP") Quality Management System ("QMS") setup under a Third-Party Logistics ("3PL") model, HSA audit coordination, and Responsible Person ("RP") sourcing support.
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PART I: STATEMENT OF WORK (SOW) & MILESTONES
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1. SCOPE OF SERVICES & DELIVERABLES
Phase 1: GDP Quality Management System (QMS) Setup & Dossier Preparation
- Preparation of tailored Standard Operating Procedures (SOPs) compliant with HSA GDP guidelines for a 3PL-outsourced operational model (including Temperature Control, Complaints & Product Recall, Supplier/Client Qualification, Risk Management, and Documentation Control).
- Assembly and review of complete application dossier for TPIL and TPWL for submission via the HSA PRISM portal.
Phase 2: PRISM Submission & Pre-Audit Verification
- Formal submission of TPIL and TPWL applications on HSA PRISM.
- Execution of pre-audit mock inspection and verification of 3PL warehouse compliance readiness.
Phase 3: HSA GDP Audit Coordination & Licence Issuance
- On-site/virtual representation and liaison with HSA inspectors during official audit.
- Preparation and submission of Corrective and Preventive Action (CAPA) responses for HSA audit findings (if any).
- Support through to final grant of TPIL and TPWL licences by HSA.
Phase 4: Responsible Person (RP) Sourcing Support
- Sourcing and initial vetting of qualified part-time Singapore-registered Pharmacists to act as Responsible Person (RP).
- Provision of candidate profiles and onboarding facilitation.
2. DELINEATION OF RESPONSIBILITIES
- Bestar Responsibilities:
* Draft all required GDP SOPs and QMS documentation tailored to Client's 3PL arrangement.
* Prepare and submit PRISM portal applications.
* Coordinate with HSA and manage technical queries.
* Source qualified RP candidates.
- Client Responsibilities:
* Provide complete and accurate corporate, product, and key personnel information in a timely manner.
* Appoint and contract directly with a licensed 3PL provider in Singapore.
* Settle official HSA statutory fees directly or reimburse Bestar promptly.
* Enter into direct employment/service engagement with the selected RP candidate.
- Third-Party (3PL / RP) Responsibilities:
* 3PL: Provide valid GDP-certified warehouse space, temperature logs, and facility SOPs.
* RP: Maintain valid registration with the Singapore Pharmacy Council and fulfill statutory duties under HSA regulations.
3. SERVICE LEVEL & RESPONSE COMMITMENTS
- Query Response: Bestar will respond to routine Client and HSA inquiries within one (1) business day.
- HSA Direct Clarifications: Formal responses to HSA regulatory queries will be prepared and submitted within three (3) business days of receipt, subject to Client providing necessary supporting documents.
4. RESPONSIBLE PERSON (RP) SOURCING CLAUSE
- Sourcing Effort: RP sourcing is undertaken on a best-effort basis. Bestar will present up to three (3) qualified Singapore-registered pharmacist profiles meeting HSA requirements within 4 weeks of engagement.
- Replacement Mechanism: Should the initially engaged RP become unavailable or prove unsuitable within 90 days of engagement, Bestar will source one (1) replacement candidate at no additional professional service charge.
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PART II: FEE SCHEDULE & PAYMENT TERMS
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1. PROFESSIONAL FEES
- Lump Sum Professional Fee: SGD 9,500.00 (Singapore Dollars Nine Thousand Five Hundred Only).
2. PAYMENT MILESTONES
- Milestone 1 (50% - SGD 4,750): Payable upon execution of this LOE/MSA (Engagement Kick-off).
- Milestone 2 (50% - SGD 4,750): Payable upon submission of TPIL and TPWL applications via HSA PRISM portal.
3. INCLUSIONS & EXCLUSIONS
- Included: Full GDP SOP drafting, PRISM preparation and submission, pre-audit mock inspection, HSA audit representation, CAPA management, and RP candidate sourcing.
- Excluded (Third-Party / Statutory Costs):
* Official HSA Application and Licence Fees (PRISM application fee, licence fees, audit fees paid directly to HSA).
* 3PL warehousing and logistics provider fees.
* Monthly/Annual remuneration payable directly to the engaged RP.
* Year 2 onward HSA licence retention fees (approx. SGD 330 per product per year payable to HSA) and recurring annual compliance retainers (quoted separately if required).
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PART III: STANDARD TERMS & CONDITIONS (MSA)
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1. CONFIDENTIALITY & PDPA COMPLIANCE
Both parties agree to hold all technical, financial, and business information received in strict confidence. Personal data supplied shall be processed strictly in accordance with the Singapore Personal Data Protection Act 2012 (PDPA).
2. LIMITATION OF LIABILITY & INDEMNITY
Bestar’s aggregate cumulative liability arising out of or in connection with this agreement shall not exceed the total professional fees actually paid by the Client hereunder. Bestar shall not be liable for regulatory rejection caused by non-compliant 3PL operations, incorrect information supplied by Client, or external policy changes by HSA.
3. TERMINATION & REFUND POLICY
Either party may terminate this agreement upon 14 days' written notice. In the event of early termination by Client, fees paid for completed milestones are non-refundable, and unbilled work completed up to the date of termination shall be invoiced on a pro-rata basis.
4. GOVERNING LAW & DISPUTE RESOLUTION
This Agreement shall be governed by and construed in accordance with the laws of the Republic of Singapore. Any dispute arising out of or in connection with this contract, including any question regarding its existence, validity, or termination, shall be referred to and finally resolved by arbitration seated in Singapore in accordance with the Arbitration Rules of the Singapore International Arbitration Centre (SIAC) for the time being in force.
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ACCEPTANCE & EXECUTION
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Please sign and return the duplicate copy of this letter to signify your formal acceptance of the terms above.
For and on behalf of
BESTAR
___________________________
Roger Pay
CEO
Accepted and Agreed by
[XYZ PTE. LTD.]
___________________________
Authorized Signatory:
Name:
Title:
Date:
Bestar Singapore HSA Licence Application
Formal Letter of Engagement (LOE) and Master Services Agreement (MSA) - HSA Licence & GDP Support
Securing a Health Sciences Authority (HSA) licence in Singapore is a critical gateway for businesses operating across medical devices, therapeutic products, Chinese Proprietary Medicines (CPM), cosmetics, and health supplements. Navigating HSA’s strict regulatory framework, Good Distribution Practice (GDP) standards, and submission protocols can present significant hurdles for foreign and local entities alike.
Bestar Singapore delivers end-to-end regulatory advisory, QMS drafting, and application management through HSA’s PRISM e-portal to streamline approval and reduce stop-clock delays.
Understanding HSA Licensing Requirements in Singapore
To import, wholesale, manufacture, or register health products in Singapore, companies must obtain regulatory clearance from the HSA under the Health Products Act and Medicines Act.
Licence Type | Scope & Covered Products | Key Prerequisites |
Wholesaler’s Licence | Wholesale distribution of medical devices, therapeutic products, or CPM. | Valid ACRA registration, local CRIS account, GDP-compliant SOPs, and storage facility layout. |
Importer’s Licence | Importing regulated medical goods into Singapore for local trade or re-export. | Appointed local responsible person, GDP certification, compliant storage & audit readiness. |
Manufacturer’s Licence | Local manufacturing or secondary assembly/repacking of health products. | Good Manufacturing Practice (GMP) compliance, quality control systems, premise audit. |
Product Registration | Registering medical devices or prescription/over-the-counter therapeutic products. | Technical dossier (ICH CTD / ACTD format), patent declaration, safety/efficacy data. |
Key Challenges in the HSA Application Process
GDP/GMP Compliance Gap: Failing to implement proper Standard Operating Procedures (SOPs) for storage, temperature logs, recalls, and quarantined stock leads to failed HSA pre-licence audits.
Regulatory Stop-Clock Delays: Incomplete technical documentation or improper evaluation route selection triggers official Queries (Queries/Clarifications), pausing the review timer and delaying market entry.
CRIS & PRISM System Setup: Overseas firms without a Singapore ACRA entity cannot directly hold a CRIS account or submit applications on PRISM.
How Bestar Singapore Streamlines Your HSA Licence Approval
Bestar Singapore acts as your end-to-end corporate and regulatory partner, bridging technical requirements with administrative compliance.
Entity Incorporation & CRIS Registration: Setting up the Singapore ACRA entity, securing CorpPass access, and establishing your Client Registration Identification Service (CRIS) account required to access HSA's PRISM portal.
Gap Analysis & GDP SOP Development: Drafting customized Good Distribution Practice (GDP) Standard Operating Procedures, covering stock segregation (quarantine, released, rejected), temperature monitoring, product recalls, and deviation management.
Facility & Warehouse Readiness: Reviewing premises layout plans to ensure compliance with HSA storage standards prior to physical inspections.
Technical Dossier Preparation & Submission: Structuring product registration dossiers into ASEAN CTD (ACTD) or ICH CTD formats, managing patent declarations, and selecting optimal evaluation routes (Full, Abridged, or Verification).
Pre-Audit Mock Inspections & Query Management: Conducting mock GDP audits to prepare management for official HSA site visits and handling post-submission queries promptly to prevent clock-stops.
The HSA Licence Application Roadmap
Step 1: Entity Setup & CRIS Account Registration (ACRA + CorpPass)
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Step 2: Gap Analysis & Quality Management System (QMS/SOP) Drafting
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Step 3: Facility Preparation & Mock GDP Audit
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Step 4: PRISM E-Submission (Dossier & Statutory Declarations)
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Step 5: HSA Physical Audit & Query Resolution
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Step 6: Licence Approval & Annual Compliance Maintenance
Frequently Asked Questions
Can a foreign company apply for an HSA licence directly?
No. Applicants must be a local entity registered with ACRA. Foreign firms can incorporate a Singapore subsidiary or engage local regulatory representatives like Bestar to handle submissions.
How long does it take to obtain an HSA Wholesaler or Importer Licence?
Preparation and dossier compilation typically take 2–4 weeks. Upon PRISM submission, HSA evaluation and site audit usually take 10 to 60 working days, depending on documentation completeness and response promptness to HSA queries.
What happens during an HSA Good Distribution Practice (GDP) audit?
An HSA auditor inspects your storage facility, temperature control systems, pest control logs, SOP documentation, staff training records, and stock segregation procedures.
Partner with Bestar to Fast-Track Your Singapore HSA Compliance
Navigating HSA regulatory frameworks, GDP audits, and PRISM submissions requires precision. Bestar handles the full compliance lifecycle—from ACRA incorporation and CRIS setup to SOP drafting, pre-audit mock inspections, and technical dossier submissions.
Ready to launch your health product or medical device business in Singapore?
Direct Email: admin@bestar-asia.com
Phone / WhatsApp: +65 6299 6688 / +65 8836 4489
Office Location: Singapore
Contact our regulatory specialists today to schedule an initial consultation and receive a customized roadmap for your HSA licence application.
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