The Quality to Trust On ︎

Our Quality Policy︎IS YOUR SAFETY

The Quality of our products is an essential requisite for us, prior to release it to the

market. So GMPs are applied from the early steps of sourcing any starting material and

all-thru the production process to guarantee the Total Quality Assurance of

final product and Client Satisfaction. ︎

2 ︎Quality to Trust On ︎

PROCESSING CONTROLS ︎TO PREVENT ERRORS

ND Pharma & Biotech Company Limited, is a Research-Based Globa l B iopharmaceut ica l , Biotechnological and Chemical Company that discovers, develops and commercializes innovative medicines in areas of unmet medical needs as well as is operating and conducting businesses in many other fields and sectors, most of them related to human health as food, nutrition, biosciences, neurosciences, industrial solutions, agrochemicals and some other. ︎︎

ND Pharma & Biotech Company brings world-class science and products to the global marketplace in the form of innovative products, materials and services. ︎︎

From controlled production processes to our strict adhesion to GMPs with well defined PROCEDURES and ANALYSIS at every critical step of production, we audit every and all plants working for us both as operated and/or in partnership. ︎︎

Manufacturing processes include a record of all raw data and every critical procedure and parameter thoroughly described for workers and double-checked in a MBR (Master Batch Record) Library. ︎︎

Our system includes controls on: ︎︎

-  Starting Materials and manufactured parameters. ︎-  Solvents, residuals, etc. ︎-  Compliance with different Regulations. ︎-  Conditions of production. ︎-  Concentration. ︎-  Purification. ︎-  Drying/Liquefaction/Transformation. ︎-  Packaging/labeling. ︎-  Cleaning. ︎-  Equipment Adjustment. ︎-  Conditioning. ︎

Quality to Trust On ︎ 3 ︎

CHECK and ︎ONCE CHECKED ︎CHECK AGAIN

Finished product, no matter use and destination undergoes a final analysis and documentary review. This thorough examination ensures not just compliance with specifications and standards. Lead ing -edge techno logy and ana ly t i ca l instrumentation is employed including NMR and HPLC, in strict accordance with suitable, verifiable and validated analytical methods, determination standards and conformation references. ︎︎

Final State involves quality assurance/control review that may include: ︎︎

MBR Documentation review ︎Analytical controls including, but not limited to: ︎︎

-  Content of Active Principles︎-  Content of impurities︎-  Heavy Metals︎-  Pesticides︎-  Residual solvents︎-  Etc. ︎

Physical analysis ︎Microbiological analysis of final product︎︎

In addition, equipment qualification and periodical maintenance is assured, for a premium quality check in every step that it´s made. ︎︎︎︎︎︎︎︎︎︎︎︎︎

Only after observing and taking all this steps in every phase are we confident that our products are ready to enter the market.

4 ︎

An Offer of +170.000 References︎︎

+750 Basic Product References. ︎+62.000 Refs. in ︎

Fine Chemicals. ︎+23.000 References in ︎

Industrial Chemicals. ︎+150.000 NCE´s ︎

Novel Chemical Entities︎+80 Brands in Food & Nutrition ︎

+21 Refs. of a single-family-brand PreserFoodTM︎

+6 Brands of Agribusiness︎+23 Brands of Pharmacy and OTC ︎

+9 Consumer Brands︎+15 Lines of Non-controversial ︎

Stem Cells︎

Quality to Trust On ︎

Quality you can ︎TRUST ON

More than 30 quality controls from starting materials to finished products conforms the ND Pharma & Biotech Company pre-requisite and the unique reliable foundation and grounds to establish a production system that creates value and marks the difference. ︎︎

ND Pharma & Biotech Co. is committed with continuous improvement and TQA (Total Quality Assurance) being actively involved in the process of help and collaborate with different agents and operators, to define regulatory environment, satisfying both authorities and customers. ︎︎

Well established and strong TQA Systems ensures that quality is built-in into the products, from the very beginning to the final processes prior to dispatching it for market circulation, use and/or transformation within any other elaborated one. ︎︎

The quality of a product is controlled during all stages of the manufacturing process by adherence to different standards internationally approved and recognized, but mostly under GMPs and extensive testing and control. ︎︎

Only when our Scientific Officers are fully satisfied, a product qualifies to enter in the market and circulation. ︎︎

Our process doesn´t stops at this stage. Our Scientific Office is developing constantly new analytical methods to ensure that products offered are in accordance with the state-of-the art, ad minimum.

5 ︎Quality to Trust On ︎

About ︎ACCREDITATION and voluntary︎CERTIFICATIONS

Ensuring the safety and security of food products is a shared responsibility between the public and private sectors. This is why we are Registered with the competent authorities responsible to establish regulatory standards, inspect facilities, and take action if there are violations, but conscious that industry has the primary responsibility to ensure that food products intended for human and animal consumption in the EU, the US or elsewhere are safe and meet applicable FDA/EC/EU requirements and standards we require form our partners, production plants and industrial suppliers to pass and meet certain processes. Those include ND Pharma & Biotech Co Quality Mark® Certification and many other Certification programs that may help industry to improve and fulfill its responsibility by providing an independent evaluation of an establishment’s Food/Pharma safety system and, if a problem is discovered, by providing information that can help a firm to fix the problem. ︎︎So our partners and suppliers are required to have implemented quality systems to ensure they are adhered to international quality and safety standards and if possible to attain other certifications although such are understood that are strictly voluntary. ︎︎We review in a continuous evaluation system verifying with certifying regulators and agencies that our providers, suppliers and production plants have all the mandatory accreditations and their licenses were not revoked and/or suspended. ︎︎On average Certifications we ask for GMP, GMP+, IFS, BRC, ISO, HACP, and many other worldwide recognized and accepted. ︎︎

6 ︎

Quality to Trust On ︎

ND Pharma & Biotech Company thoroughly audits and inspects every production facility manufacturing, supplying, transforming, packing or working for us. We require up-to-date official permits and licenses, certifications obtained and to pass satisfactorily our up-standard requirements prior to being part of our network and maintaining such status all the time our relationship may last.

Glossary of︎TERMS ︎

7 ︎

Quality to Trust On ︎

Accreditation means an attestation related to a certification body (but not by the certification body itself) conveying formal demonstration of its competence to carry out specific certification tasks. Accreditation body means an authoritative body that performs accreditation. Attributes mean the characteristics of a certification body that regulators intends to consider when evaluating whether its certifications are a reliable reflection that food/products from establishments a certification body certifies meets the certification criteria. Audit means the systematic and functionally independent examination of a product, process, and establishment, including records and laboratory testing, as appropriate, to determine an establishment’s conformance with certification criteria. Audit activities may include a range of activities, such as on-site examinations of establishments, review of records, review of quality assurance systems, and examination or laboratory testing of product samples. Auditor means a person acting for the certification body who conducts audits and makes a determination of the degree to which certification criteria have been met by an establishment for a particular product type. Certification means the procedure by which a certification body provides assurance that the establishment conforms to certification criteria. Certification should be granted for particular product types produced, manufactured, processed, packed, or held by the establishment. Certification should be, as appropriate, based on a range of audit activities established in our internal control guides. Certification body means a third-party organization that operates a certification program. A certification body could be a Federal, State, local, or foreign government agency, as well as a non-government entity that is independent of the businesses it certifies and free from conflicts of interest. Certification criteria mean those criteria used by the certification body during an audit to determine whether an establishment should receive certification. Certification criteria for the purpose of this document should, at a minimum, include applicable FDA requirements. Certification program means a third-party system that verifies, through audits, an establishment’s conformance with certification criteria. Certification program assessment means a systematic examination by ND Pharma & Biotech - Intabiotech to assess a certification body’s conformance with the attributes settled within our manuals and guides. Establishment means a site-specific domestic or foreign facility that produces, manufactures, processes, packs, or holds food for use, consumption, or further processing in the EU/US (applicable to elsewhere). Inspection means the examination of a product, process, or establishment, including records and laboratory testing, performed by ND Pharma & Biotech aside of governmental entities or any other acting under authority, such as a State regulatory authority. Self-assessment means a certification body’s systematic assessment to determine whether its activities and related results meet planned objectives (e.g., the attributes in this document). Third party means an organization other than the establishment or ND Pharma & Biotech – Intabiotech. A third party could include a Federal, State, local, or foreign government authority that is not conducting inspections, as well as a private entity.

Directory/Contacts ︎FEEL FREE TO CONTACT US

Board of Directors︎︎CEO (Chief Executive Officer) ︎and VP of the Board ︎︎

ceo@ndpharmabiotech.com︎

︎CSO (Chief Scientific Officer) ︎︎

cso@ndpharmabiotech.com︎︎CCO (Chief Circulation Officer) ︎international@ndpharmabiotech.com︎︎CLO (Chief Legal Officer) ︎legal@ndpharmabiotech.com︎︎CFO (Chief Financial Officer) ︎cfo@ndpharmabiotech.com︎︎CCO (Chief Compliance Officer) ︎compliance@ndpharmabiotech.com︎︎GS (General Secretary) ︎secretary@ndpharmabiotech.com︎︎GCO (General Corporate Officer) ︎corporare@ndpharmabiotech.com︎

Administration / Services︎︎Administration (Central) ︎admon@ndpharmabiotech.com︎︎Corporate Services (Central) ︎corporate@ndpharmabiotech.com︎︎Legal Office (Central) ︎legal.ndpharma@europe.com︎︎Comptrol Office (Central) ︎sr.ndpharma@europe.com ︎︎Marketing/Publications Service︎marketing@ndpharmabiotech.com︎︎Business Development Office︎bdu.ndpharma@europe.com ︎︎Business Intelligence Unit︎biu.ndpharma@eruope.com︎︎Research Centre︎ndpharmabiotech@tech-center.com︎︎Regulation Office︎regulation.ndpharma@europe.com︎︎Regulatory Office (Intabiotech) ︎regulatory@intabiotech.com︎

General︎︎General Information Point︎info@ndpharmabiotech.com︎︎General Services (Central) ︎ndpharmabiotech@europe.com︎

Commercial/ Services︎︎International Director ︎international@ndpharmabiotech.com︎︎Commercial Branch ︎intabiotech@intabiotech.com︎︎Commercial Coordination ︎intabiotech@europe.com︎︎Legal Office – Commercial︎legal@intabiotech.com︎︎Commercial General (French Speaking Countries) ︎commercial@ndpharmabiotech.com︎︎Commercial (Eastern/Central Europe︎iulia.dumitrascu@ndpharmabiotech.com︎︎Industrial Division ︎industrial@ndpharmabiotech.com︎︎Chemical Division ︎ndpharmabiotech@chemist.com︎︎Commercial (Labs Division) ︎s.pico@ndpharmabiotech.com︎︎Commercial (Iberia) ︎jr.castells@ndpharmabiotech.com︎︎Commercial (Latin American Countries) General︎latam@ndpharmabiotech.com︎︎Commercial (LATAM Countries) Delegate︎mv.ndpharma@samerica.com︎

8 ︎

Subsidiaries︎︎GLAICE︎General Information Point︎info@glaice.info︎︎The Glaice Water Co. ︎glaice@usa.com︎glaicewater@usa.com︎︎ALKIOW ︎alkiow@europe.com︎︎ND Innovation ︎ndinnovation@europe.com︎ndinnovation@usa.com︎

Quality to Trust On ︎

ND Pharma & Biotech is a Company Limited by Shares Registered in England and Wales under Companies Act 2006. Capital 210.000.100 Shares of 1£/Share. ︎︎Registered Office in Surrey, England, UK︎Corporate Offices in London, England, UK︎︎

World Presence︎Production Centers, Partners and Distributors in 26 Countries

NDPharma&BiotechCo.RegisteredOffice,Surrey,EnglandCorporateOffices,London,EnglandResearch+Innova=onCentre,Dorset,UKLogis=cs,Newcastle,UK

With Partners and Distributors Worldwide we are proudly operating in 5 Continents.

We can serve each client with a global perspective throug on local basis, as preferred

Contact Us: ︎General Regional Areas

︎Europe, Middle East & Africa︎

ndpharmabiotech@europe.com︎︎

North America︎ndpharmabiotech@usa.com︎

︎Latin American Countries︎

ndpharmabiotech@samerica.com︎︎

Asia-Pacific ︎ndpharmabiotech@asia.com︎

︎

NDPharma·IntabiotechSLURegisteredOffice,Valencia,SpainCorporateOffices,Paterna,SpainPharmaDivision,Madrid,SpainCommercialDivision,LaCoruña,SpainIndustrialDivision,Narón,SpainLogis=cs/Control,Tarragona,Spain

9 ︎Quality to Trust On ︎

www.ndpharmabiotech.com