Pharmaceutical Product Solutions

TEL Expert Solutions | Managed by Experts. Overseen by Experts.

Pharmaceutical Products

Ensure the highest quality, safety, and regulatory compliance of your pharmaceutical products with TEL Expert Solution's comprehensive pharmaceutical solutions. Our expert team offers consulting services to guide you through GMP and GxP compliance, helping you implement the right systems and processes to meet industry standards. We coordinate testing services with ISO 17025-accredited and GMP-compliant laboratories, ensuring your products meet rigorous safety and efficacy standards. To further safeguard product integrity, our quality auditing services assess both your internal processes and those of your suppliers, identifying potential gaps and driving continuous improvements to maintain strict GMP and GxP compliance.

Trust TEL Expert Solutions to deliver solutions that ensure your products consistently meet the highest standards of pharmaceutical quality and regulatory compliance at every stage of the process.

OUR SERVICES

In the fast-paced and highly regulated pharmaceutical industry, ensuring the safety, efficacy, and compliance of drug products is paramount. TEL Expert Solutions delivers end-to-end solutions that help pharmaceutical companies navigate the complexities of regulatory requirements, quality assurance, and testing. With a focus on GMP and GxP standards, we offer expert consulting, auditing, and testing services that ensure your products meet the highest industry benchmarks.

We partner with you to ensure your operations comply with stringent regulatory standards at every stage, from quality management and cold chain logistics to product testing and auditing. Our team works closely with you to optimize your processes, prevent potential risks, and maintain the integrity of your products.

By leveraging our deep expertise and experience in GMP and GxP compliance and pharmaceutical quality assurance, we help you achieve a competitive advantage while ensuring public health and safety remain top priorities.

Consulting Solutions

  • Ease through the registration process of your product with the relevant authorities with the expertise of TEL Expert Solutions.

    Service includes:

    • Advice, support and/or review of your documentation for your product prior to submission to relevant regulatory

  • Navigate the complexity of GMP or GxP requirements on your subject matter with our expert advice and support.

    Service includes one or more of the following:

    • Advice and/or support to meet GMP requirements on subject matter

    • Provision of relevant GMP or GxP documentation templates

  • Move your company’s quality management system to a GMP- or GxP-compliant environment with our comprehensive consulting services.

    Service includes

    • Advice and support to transit your company to a GMP or GXP environment

    • Training for employees on GMP or GxP knowledge

    • Access to our depository of GMP and GxP documentation templates

  • Leverage our professional documentation drafting and review services to help your company meet GMP or GxP requirements with efficiency and effectiveness.

    Selected Examples of GMP and GxP Documentation

    • Quality Statement and Policy Templates

    • Quality Manual (QM) Templates

    • Standard Operating Procedure (SOP) Templates

    • Work Instructions (WI) Templates

    • Risk Assessments (RA) Templates

    • Test Method Templates

    • Test-Related Excel Worksheets Templates

    Request for customised templates and/or content may be supported for additional charge.

  • Develop, validate and verify your test methods to guarantee accuracy, precision and compliance for GMP excellence.

    Service includes one or more of the following:

    • Advice, support and/or training relating to method development, validation and/or verification

    • Literature review of current methodologies, including test methods within standards and/or compendia, for the method development

    • Documentation and/or test coordination support with accredited third-party laboratories for method validation or verification

    Common Parameters Found in Method Development, Validation and Verification

    • Specificity

    • Linearity

    • Limit of Detection (LOD)

    • Limit of Quantification (LOQ)

    • Precision

    • Accuracy

    • Robustness

  • Enhance your company’s cold chain management through compliance with GMP requirements.

    Service includes one or more of the following:

    • Advice, support and/or training to meet GMP requirements relating to cold chain management

    • Support for qualification of cold chain equipment or vehicles

Quality Auditing Solutions

  • Evaluates the OOS result and its investigation processes, ensuring the root cause was correctly identified and verifying the status of corrective and preventive actions (CAPA) implementation.

    TEL Expert Solutions employs the 5M1E Method with an emphasis on technical and quality aspects to comprehensively assess the investigation.

    A typical OOS investigation audit includes a review or verification of the following:

    • Method : Assessing the relevant standard operating procedures (SOPs), the suitability of the test method, its currentness, validation or verification documentation, change control records, and more.

    • Man : Evaluating the personnel involved, including their qualifications, training, experience, and more.

    • Machine : Reviewing the fit-for-purpose status of equipment, qualification and calibration records, instrument audit trails, and more.

    • Materials : Ensuring proper supplier qualification, suitability of materials, review of material’s certificates of analysis, and more.

    • Measurement : Analysing test results, trend data, process documentation, audit trails, deviations, and more.

    • Environment : Reviewing the suitability of the working, production, and storage environment.

  • Reviews and evaluates your company's procedures and processes to ensure the system conforms to a quality standard.

    A typical internal audit includes the following:

    • Determination of Audit Scope and creation of Audit Programme with customer

    • Implementation of Internal Audit on relevant departments, offices, production lines and/or laboratories

    • Provision of Audit Report to customer

    • Support in reviewing of Corrective and Preventive Actions (CAPAs) with customer

  • Evaluates and assesses your supplier’s compliance to your company's quality standards and requirements.

    A typical internal audit includes the following:

    • Determination of Audit Scope with customer

    • Coordination with all relevant auditees, and development of Audit Programme with customer

    • Implementation of Audit on relevant departments, offices, production lines and/or laboratories

    • Sharing and discussion of Audit Findings with customer

    • Provision of Audit Report to customer and corresponding auditee

    • Support in expedition and review of Corrective and Preventive Actions (CAPAs) from all auditees with customer

Product Testing Solutions

  • Authenticates the presence of drug component(s) within the product using chemical, physiochemical, or biochemical methods.

    Commonly Laboratory Techniques Used Identification Tests

    • Chemical Methods, incorporating colour reactions, precipitation formation reactions, gas-generating reactions, flame tests, reagent, and more

    • Spectral Methods, incorporating infrared (IR) spectroscopy, ultraviolet-visible (uv-vis) spectrophotometry, and more

    • Chromatographic Methods, incorporating thin layer chromatography (TLC), high performance liquid chromatography (HPLC), gas chromatography (GC), and more

  • Quantifies the amount or functional activity of drug component(s) within a product.

    Common Laboratory Techniques Used in Assay Tests

    • Titrimetry

    • Ultraviolet-Visible (UV-Vis) Spectrophotometry

    • High Performance Liquid Chromatography (HPLC) with ultraviolet detector (UV), diode array detector (DAD), fluorescence detector (FLD), refractive index Detector (RID), evaporative light scattering detector (ELSD), and more

    • Gas Chromatography (GC) with flame ionization detector (FID), mass selective detector (MSD), and more

    • Atomic Absorption Spectrometry (AAS)

  • Determines the degree of uniformity in the amount of drug component(s) among dosage units.

    Commonly abbreviated as UOC (uniformity of content) or CU (content uniformity) in pharmaceutical testing.

    Common Laboratory Techniques Used in Uniformity of Content Tests

    • Titrimetry

    • Ultraviolet-Visible (UV-Vis) Spectrophotometry

    • High Performance Liquid Chromatography (HPLC) with ultraviolet detector (UV), diode array detector (DAD), fluorescence detector (FLD), refractive index Detector (RID), evaporative light scattering detector (ELSD), and more

    • Gas Chromatography (GC) with flame ionization detector (FID), mass selective detector (MSD), and more

    • Atomic Absorption Spectrometry (AAS)

  • Measures the rate and extent to which drug component(s) is/are released from a dosage form into a solution over a specified period.

    Common Laboratory Techniques Used in Dissolution Tests

    • Titrimetry

    • Ultraviolet-Visible (UV-Vis) Spectrophotometry

    • High Performance Liquid Chromatography (HPLC) with ultraviolet detector (UV), diode array detector (DAD), fluorescence detector (FLD), refractive index Detector (RID), evaporative light scattering detector (ELSD), and more

    • Gas Chromatography (GC) with flame ionization detector (FID), mass selective detector (MSD), and more

  • Measures the time taken for tablets or capsules to break down into smaller fragments when immersed in a liquid medium.

  • Determines the quantity of by-product(s) of synthesis or degradation product(s) of drug component(s) within a product.

    Common Laboratory Techniques Used in Organic Impurities or Related Substances Tests

    • High Performance Liquid Chromatography (HPLC) with ultraviolet detector (UV), diode array detector (DAD), fluorescence detector (FLD), refractive index Detector (RID), evaporative light scattering detector (ELSD), and more

    • Gas Chromatography (GC) with flame ionization detector (FID), mass selective detector (MSD), and more

    • Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS)

  • Determines the levels of elemental impurities that may originate from residual catalysts, process-related impurities, migration from contact materials, or trace contaminants within the drug component(s) of the product.

    Common Laboratory Techniques Used in Elemental Impurities Tests

    • Inductively Coupled Plasma with optical emission spectrometer (ICP-OES), mass spectrometer (ICP-MS), and more

    • Ion Chromatography (IC) with conductivity detector (CD), electrochemical detector (ECD), and more

  • Determines the number of undissolved particles of 10 µm or larger, and 25 µm or larger, in a volume of sample that are unintentionally present in the product.

    Common Methods Used in Particulate Matter Tests

    • Light Obscuration Particle Count

    • Microscopic Particle Count

  • Evaluates the mechanical strength of tablets to ensure the dosage form can withstand handling, packaging, and transportation without breaking or crumbling.

  • Measures the force required to break a tablet by applying tension or bending pressure to the dosage form.

  • Identifies leaks or defects in packaging that may compromise the product's integrity.

  • Detects trace amounts of organic volatile chemicals used or produced during the manufacture of drug substances, excipients, or drug products.

    Common Laboratory Techniques Used in Residual Solvent Tests

    • Headspace-Gas Chromatography (HS-GC) with flame ionization detector (FID), mass selective detector (MSD), and more

  • Determine the level of microbial contamination in finished drug formulations to ensure the product meets microbiological quality standards and is safe for patient use.

    Selected Examples of Microbial Limit Test Parameters

    • Total Aerobic Microbial Count (TAMC)

    • Total Yeast and Mold Count (TYMC)

    • Bacterial Endotoxin Test (LAL Test)

    • Sterility Testing (for sterile products)

  • Review the stability of your product with testing of key quality and safety test parameters after storage.

    Standard ICH Storage Conditions

    • 25 °C/60% RH - Real time storage condition

    • 30 °C/65% RH - Intermediate storage condition

    • 40 °C/75% RH - Accelerated storage condition

    Common key quality and safety parameters include:

    • Assay

    • Organic Impurities and Related Substances

    • Microbial Limit Tests

SCOPE OF SERVICES

Relevant Products

Our consulting, testing and auditing services encompass a wide range of finished pharmaceutical products including, but not limited to:

  • Parenteral Products, including injections, implanted drug products, sterile powders for solutions, suspensions, emulsions, and more

  • Oral Drug Products, including tablets, capsules, granules, salts, powders, liquids, and more

  • Topical and Transdermal Drug Products, including creams, gels, ointments, lotions, and more

  • Inhalation and Nasal Drug Products, including aerosols, sprays, powders, and more

Relevant Regulatory or Authority Organisations

TEL Expert Solutions adheres to the following key regulations and standards in the provision of our services:

  • Singapore - Health Sciences Authority (HSA)
    Health Products (Therapeutic Products) Regulations 2016

  • World Health Organisation (WHO)
    WHO Prequalification of Medicines Programme (PQP)

  • United States of America (USA) - U.S. Food and Drug Administration (FDA)
    Federal Food, Drug, and Cosmetic Act (FD&C Act)

  • European Union (EU)
    Regulation (EC) No 726/2004

If you require assistance with regulations from other countries or authorities, we are available to review and provide expert guidance tailored to your specific requirements.

Relevant Official Standards, Compendia and Guidelines

TEL Expert Solutions references the following key official standards, compendia and guidelines in the provision of our services:

  • United States Pharmacopoeia (USP)

  • British Pharmacopoeia (BP)

  • European Pharmacopoeia (Ph. Eur.)

  • Chinese Pharmacopoeia (ChP)

  • Japanese Pharmacopoeia (JP)

  • Indian Pharmacopoeia (IP)

  • International Pharmacopoeia (Ph. Int.)

  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines

If you require assistance with standards or compendia not listed above, we are available to review and provide expert guidance tailored to your specific needs.

PRICING STRUCTURE

Pharmaceutical Consulting Solutions

Please note that pricing may vary depending on the complexity of the project.

Product Registration
From SGD 2,500 (inclusive of GST) per product

General GMP or GxP Consultation
From SGD 300 (inclusive of GST) per hour
From SGD 2,500 (inclusive of GST) per project

GMP or GxP Setup and Implementation
From SGD 40,000 (inclusive of GST) per system per entity

GMP and GxP Documentation Support
From SGD 250 (inclusive of GST) per document

Method Development, Validation and Verification
From SGD 3,500 (inclusive of GST) per verification per test method
From SGD 8,000 (inclusive of GST) per validation per test method
From SGD 16,000 (inclusive of GST) per method for developement

Cold Chain Storage and Transportation
From SGD 2,500 (inclusive of GST) per project

Pharmaceutical Testing Solutions

Due to the complexity of testing, pricing may vary based on factors such as the quality management system required for testing, parameters, test method, sample preparation requirements, analytical techniques, instrumentation, detectors, detection limits, cost of chemical reference standards and/or storage conditions.

Physiochemical Method, including pH Tests, Viscosity Tests, and more
From SGD 50 (inclusive of GST) per test [testing under ISO 17025 requirements]
From SGD 100 (inclusive of GST) per test [testing under GMP requirements]

Gravimetric Method
From SGD 80 (inclusive of GST) per test [testing under ISO 17025 requirements]
From SGD 160 (inclusive of GST) per test [testing under GMP requirements]

Titrimetric Method
From SGD 100 (inclusive of GST) per test [testing under ISO 17025 requirements]
From SGD 200 (inclusive of GST) per test [testing under GMP requirements]

Elemental Analysis
From SGD 150 (inclusive of GST) per test [testing under ISO 17025 requirements]
From SGD 300 (inclusive of GST) per test [testing under GMP requirements]

UV-Vis Spectrophotometric Method
From SGD 200 (inclusive of GST) per test [testing under ISO 17025 requirements]
From SGD 400 (inclusive of GST) per test [testing under GMP requirements]

HPLC Method
From SGD 300 (inclusive of GST) per test [testing under ISO 17025 requirements]
From SGD 600 (inclusive of GST) per test [testing under GMP requirements]

GC Method
From SGD 300 (inclusive of GST) per test [testing under ISO 17025 requirements]
From SGD 600 (inclusive of GST) per test [testing under GMP requirements]

LC-MS/MS Method
From SGD 500 (inclusive of GST) per test [testing under ISO 17025 requirement]
From SGD 1,000 (inclusive of GST) per test [testing under GMP requirement]

Microbial Tests, including Limit Tests and Challenge Tests
From SGD 120 (inclusive of GST) per test [testing under ISO 17025 requirements]
From SGD 240 (inclusive of GST) per test [testing under GMP requirements]

Quality Auditing Solutions

Please note that pricing may vary depending on the scope of audit. Prices exclude travel-related expenses if the audit location is outside of Singapore.

Out-of-Specification (OOS) Investigation Audit
From SGD 1,090 (inclusive of GST) per man-day

Internal Audit (First-Party Audit)
From SGD 1,090 (inclusive of GST) per man-day

Supplier Audit (Second-Party Audit)
From SGD 1,090 (inclusive of GST) per man-day

THE PROCESS

Consulting and Product Testing Solutions

TEL Expert Solutions follows a straightforward 5-step process for our comprehensive Consulting and Product Testing Services:

STEP 1
Customer submits an enquiry.

STEP 2
Acknowledgement and additional communication or clarification from TEL Expert Solutions within 1 working day. A quotation is provided to the customer within 0 to 3 working days from confirmation of required service.

STEP 3
Customer confirms the order.

STEP 4
TEL Expert Solutions begins the formal consultation process with the customer. If testing is involved, TEL Expert Solutions arrange collection of test items with customer. These items are recorded into our system before being sent to our qualified ISO 17025-accredited partner laboratories for testing.

STEP 5
TEL Expert Solutions closes delivers the final reports and/or deliverables within the stipulated timeline.

Throughout the process, TEL Expert Solutions manages all communications with vendors or suppliers relevant to the consulting services on your behalf, ensuring a smooth and hassle-free experience. We also provide regular email updates to keep you informed on the progress and status of the service.

Quality Auditing Solutions

TEL Expert Solutions follows a straightforward 8-step process for our comprehensive Auditing Services:

STEP 1
Customer submits an enquiry.

STEP 2
Acknowledgement from TEL Expert Solutions within 1 working day and an audit specialist will be assigned to the customer to discuss details and requirements. A quotation is provided to the customer within 1 to 3 working days from confirmation of required service.

STEP 3
Customer confirms the order, and TEL Expert Solutions shall follow up with the assignment of a lead auditor to manage the enquiry.

Additionally, customer will need to send an email to their intended auditee (with TEL Expert Solutions copied) confirming that TEL Expert Solutions has been appointed as the auditor or investigator on behalf of the customer.

STEP 4
TEL Expert Solutions coordinates with the auditee to schedule the audit or investigation. Relevant documentation, such as the Audit or Investigation Agenda, is sent to the auditee. Unless otherwise requested, the customer will be copied in all email communications with the auditee.

STEP 5
TEL Expert Solutions conducts audit or investigation on behalf of customer. The customer may also appoint officers as auditors, technical experts, or observers for the audit or investigation.

STEP 6
TEL Expert Solutions delivers the Audit or Investigation Report to both the customer and the auditee. The auditee must respond with corrective and preventive actions or a CAPA (Corrective and Preventive Actions) plan, if applicable, within the agreed-upon timeline.

STEP 7
Customer reviews the actions and/or CAPA plan submitted by the auditee, with the advice and support from TEL Expert Solutions.

STEP 8
TEL Expert Solutions issues a Closing Letter to auditee if all actions and plans are deemed acceptable by the customer.

Throughout the process, TEL Expert Solutions manages all communications with the auditee on your behalf, ensuring a smooth and hassle-free experience. We also provide regular email updates to keep you informed on the progress.

Why should you work with TEL Expert Solutions?

Experienced Subject Matter Experts

From certified professionals to experienced technical experts, we provide impactful, personalized insights that drive your business forward.

Accredited Partner Laboratories for Testing

Our partner laboratories are accredited to ISO/IEC 17025:2017 by SAC-SINGLAS and recognized by local and international bodies.

Exceptional Customer Support

Our commitment to excellent customer support guarantees a seamless and responsive experience for all our customers.

Access to Technical Resources

We leverage a rich resource library of regulatory, technical and testing standards to deliver unparalleled support.

Single Point of Contact

We serve as your point of contact, streamlining communication and reducing the need to liaise with multiple stakeholders.

Timely Update of Progress and Status

We provide dynamic progress updates that keep you informed and drive you toward timely project completion.