Cekindo regulatory for healthcare and wellness in indonesia

Regulatory for Healthcare and Wellnessin Indonesia

In-Market iAdvisory WorkshopJakarta, October 2016

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Contents

Healthcare and Wellness Products

Market-entry Strategy in Indonesia

Company Profile

Product Registration

Halal Certification

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What is Cosmetics?

According to the BPOM (National Agency of Drug and Food Control in Indonesia), cosmetics is substance or preparation intended to be used on the outside of the human body (epidermis, hair, nails, lips and genital organs exterior), or teeth and oral mucous membranes, especially to clean, perfume, change the appearance, and / or improve body odor and or protect or maintain the body in good condition.

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Cosmetic Category in Indonesia (1)• Creams, emulsions, lotions, gels and oils for skin (hand, face,

feet, etc.)• Face masks (with the exception of chemical peeling products)• Tinted bases (liquids, pastes, powders)• Make-up powders, after-bath powder, hygienic powders, etc• Toilet soaps, deodorant soaps, etc• Perfumes, toilet waters and eau de Cologne• Bath or shower preparations (salts, foams, oils, gels, etc)• Depilatories•Deodorants and anti-perspirants• Hair Care products

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Cosmetic Category in Indonesia (2)• Shaving product (creams, foams, lotions, etc)• Product for making-up and removing make-up from face and

the eyes• Product intended for applications to lips• Product for care of the teeth and the mouth• Product for nail care and make-up• Product for external intimate hygiene• Sunbathing products• Products for tanning without sun• Skin Whitening products• Anti-wrinkle products

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What is Food Supplement?

According to the BPOM (National Agency of Drug and Food Control in Indonesia), food supplement is • products that are intended to

supply the nutritional needs, • maintain, enhance and improve

health functioning, • contain one or more ingredients

such as vitamins, minerals, amino acids or other materials (derived from plant or not plant) that has nutritional value and / or physiological effects,

• that are not intended as food.

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Food Supplement LabellingThe label should includes points in the following:• Word : Food Supplement (in Indonesian is “Suplemen Makanan”)• Product name• Net weight or net volume• Name and address of manufacturer or importer• Indication, direction of use and serving size / dosage• Composition / ingredients in qualitative and quantitative• Energy value per serving (in calorie) for energy drink product• Alcohol content for oral solution, if any• Expiry date, production code, and registration number• Contraindication, side effect, and warning, if any• Other information related to safety or quality or source of material

according to the provisions• Label shall be mentioned in Bahasa Indonesia language.

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Medical Devices and Household Product• Medical devices are instruments, apparatus, machines and /

or implants that does not contain a drug used to prevent, diagnose, cure and alleviate disease, caring for the sick, restore health in humans, and / or forming the structure andimprove body function.– Medical devices are divided into 4 class that are I, IIa, IIb, and III

according to the risk of the products• Household products, hereinafter referred PKRT are the tools,

materials, or a mixture of materials for the maintenance andhealthcare for humans, pet flea control, households, and public places.– Household products are divided into 3 class that are class I, II, and III

according to the risk of the products

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Pharmaceutical Products• Drugs are substances or guidance materials ready to be used

to modify or explore physiological systems or pathological states for determination of diagnosis, prevention, cure, rehabilitation, improvement of health and contraception.

• Drug classification is intended to enhance the safety and permanence of use and security distribution, which are divided into 4 categories.

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Pharmaceutical Classifications (1)

Classification Description Sample Available at Special sign

Over the counter (OTC)

Sold freely on the market and can be purchased without a prescription

ParasetamolVitamin

Store/shopDrug storePharmacy

OTC limited(List W)

Actually include hard drugs, but still can be purchased over the counter without a prescription

CTMAntimoNoza

Drug storePharmacy (without prescription)

Accompanied by a warning sign

Prescription drugs (List G)

Can only be purchased in pharmacies by prescription

Asam MefenamatAntibioticsMedicine contain hormones

Pharmacy (should be by prescription)

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Pharmaceutical Classifications (2)

Classification Description Sample Available at Special sign

Narcotic and Psychotropic Drugs (List O)

- Psychotropic drugs are hard drugs either natural or synthetic non-narcotic, efficacious psychoactive through selective effect on the central nervous system that causes typical changes in mental activity and behavior

- Narcotic drug is a drug derived from a plant or not plant either synthetic or semi-synthetic that can cause a decrease or change of consciousness, loss of taste, reduce to relieve pain and cause dependence

- Diazepam, Phenobarbital, Ecstasy, Crystal meth

- Morphine, Pethidine

Pharmacy (should be by prescription)

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Drugs Advertisement• Drugs that can be advertised is a drug that is classified in a Over The

Counter (OTC) drugs or OTC limited drugs• Ads can be published in the media after approval from the Ministry of

Health and the name is according to the registration• Ads should include information on:

– The composition of the active drug substance with the INN name (for print media); to other media, if you want to mention the active ingredient, should be named INN

– The main indications of drugs and drug safety information– Drugs Trading Name– Pharmaceutical Industry Name– Registration Number (special print)

• Ads should not be performed by healthcare professionals or actors who played the health professions

• Ads must not give superlative statement, comparative, about indications, uses or benefits of the drug

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Drugs Advertisement• Ads must contain a recommendation to seek the right information

to healthcare professionals regarding specific health conditions• Ads should not encourage excessive and continuous use and may

not show the effects of drugs immediately after drug use• Ads should not offer prizes or provide warranty statements

regarding indications, uses or benefits of the drug• Ads should not be aimed at audiences of children or featuring

children without adult supervision. Ads can not describe that the decision to use medications taken by children

• Ads should include spot warning as follows:– BACA ATURAN PAKAI (Read Rules of Use)– BILA SAKIT BERLANJUT, HUBUNGI DOKTER (If ill persists, call a doctor)

• Except for vitamins, spot warning attention as follows:– BACA ATURAN PAKAI (Read Rules of Use)

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Drugs Packaging and Labelling

The label should includes points in the following:• Drug name• Dosage forms• Packaging size (unit)• Name and strength of the active substance• Name and address of the registrant• Name and address of the manufacturer• Name and address of the licensor• Administration of use• Marketing authorization number

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Drugs Packaging and Labelling

• Batch number• Production date• Expiry date• Indication• Posology• Contraindications• Side effects• Drug interactions• Warning-attention

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Contents

Background of Food Supplement in Indonesia


Company Profile


Halal Certification

How to Enter Indonesian Market?

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• The decision to enter new market is critical, particularly in Asia. Indonesian market is one of the most potential market to be entered in Southeast Asia with relatively high bureaucracy system.

• As we understand the local market specifics and take advantage of our extensive network, we aim to provide an updated information and assistance to foreign entities and entrepreneurs to support their business in Indonesia.

• There are two options prior to enter Indonesian market. 1. Company Incorporation2. Cooperation with Local Partner

Company Incorporation

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1. Minimum 2 shareholders, 1 director and 1 commissioner2. Business activities determine percentage allowed for foreign

ownership3. Minimum investment plan IDR 10.000.000.000 & 25% paid up

capital4. IUT (Permanent Business

License) can be obtained after realization of investment

5. Other license can be obtained after IUT is obtained

Foreign Owned Company (PT. PMA)

1. Minimum 2 shareholders, 1 director and 1 commissioner 2. Shareholders & commissioner required local and at least 1 local director3. There are 3 sizes of local PT : - small - medium - large 4. If company plans to hire foreign, medium size with capital IDR 1.000.000.000 is required

Local Company (PT)

1. Limited only for market studies, marketing, promotion and not allowed to generate revenue2. No shareholder requirement3. No director and commissioner requirement4. No capital requirement5. Minimum 1 Chief of Representative Office

Representative Office

Foreign Owned Company (PT. PMA)

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2 days

• Approval of company name at Ministry of Law and Human Rights

15 days

• Approval of Principal License at the Indonesian Investment Coordinating Board

4 days

• Preparation of Article of Association

3 days

• Obtain Deed of Establishment at Ministry of Law and Human Rights

15 days

• Obtain Certificate of Domicile at the local government office

3 days

• Obtain tax payer registration number (NPWP)

10 days

• Obtain Company Registration Certificate at the local government

• Regulations of PT. PMA

Time process approximately 2,5 monthsThe investment plan IDR 10.000.000.000

should be spent and can include non financial investment

The time given is 1 year to fulfill the investment and can be extended 2 years

Permanent business license (IUT) can be obtained after realization around 1 year

The double investment is implemented to have more than 1 business activities

Any licenses e.g. Import license in order to support the business can be obtained after IUT is obtained

Local Company (PT)

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2 days• Approval of company name at Ministry of

Law and Human Rights

4 days• Preparation of Article of Association

3 days• Obtain Deed of Establishment at Ministry of

Law and Human Rights

15 days


3 days• Obtain tax payer registration number

(NPWP)

10 days

• Obtain Trading Business License

10 days

• Obtain Company Registration Certificate at the local government

• Regulations of local company (PT)

Time process approximately 2 monthsThere are 3 types according to the mount

of paid in capital :1.Small : IDR 50.000.000 - 500.000.0002.Medium : IDR > 500.000.000 -

10.000.000.000 3.Large : IDR > 10.000.000.000

Medium size of company with minimum capital IDR 1.000.0000 is required to employ 1 foreign employee

Maximum 3 (three) business activitiesAfter company is established, company is

automatically obtain business license (SIUP)Any other licenses can be obtained after

company is established

Representative Office

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15 days

• Approval of representative office by BKPM

15 days


3 days

• Obtain tax payer registration number (NPWP)

15 days

• Obtain Company Registration Certificate at the local government office

• Regulations of Representative Office

Time process approximately 2 monthsThe transactions shall be done through the

mother company There is no minimum investment,

shareholders, director and commissioner requirement

The Representative Office shall be located in the office building or commercial area

There are 3 types of Representative Office 1.Representative Office (KPPA)2.Trading Representative Office (KP3A)3.Construction Representative Office

(BUJKA)

Cooperation with Local Partner

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• Aside from incorporation, other way to enter Indonesian market is to cooperate with local partners e.g local distributors.

• The distributors are the key players in the market, hence prior to appoint the partners and distributors, ensure and review the distributor’s background is highly recommended.

• As a consulting firm, we have wide experience in assisting foreign entities and entrepreneurs in finding potential local distributors to develop the business in Indonesia. We help finding them the potential distributors based on requirements needed.

• Alternatively, Cekindo can assist to hold the product license under Cekindo.

Several steps to encourage potential distributors:

Listing the requirements

Shortlisting the potential distributors based on the requirements

Company review to clarify the background of the distributors

Conduct and arrange initial meetings with potential distributors

Negotiations and dealing

Close deal

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Contents



Company Profile


Halal Certification

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Product Registration Overview

• The National Agency of Drug and Food Control (Indonesian acronym BPOM) is responsible to regulate and control the registration, distribution, and quality of cosmetics, food supplement, drugs, foods, etc.

• Products above shall be registered at BPOM and medical devices shall be registered at the Ministry of Health to obtain registration number of products to be able to be distributed legally in Indonesia.

• The products shall be registered under Indonesian company, as distributor or agent in Indonesia (it is not allowed to be registered by foreign company or individual).

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• The product license is valid for 3 years only under 1 company. Meaning that after registration, this company will receive some kind of exclusivity on the products, since this company holds the product license and without their approval, the principal or exporter is not able to change the company or make any registration under the other distributor.

• Cosmetics registration in Indonesia takes around 1,5 - 2 months. The registration lifetime of cosmetics is until 3 years as long as still meeting the prevailing provisions and extendable through re-registration of cosmetics product.

Cosmetics Registration Timeframe

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Cosmetics Registration Process – Legal Entity Registration

Fill out legal entity online registration form

1

Submit legal entity hard copy documents to BPOM

2

Verification process3

Login data is activated and able to register products

4 Returned to be completed or corrected

5

Complete Incomplete

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Cosmetics Registration Process – Product Registration

Fill out product online registration form

1

Submit product hard copy documents to BPOM

2

Payment to BPOM3

Payment verification4 Product ID issued5

Incorrect

Correct

Rejected to be corrected or completed

7bBPOM Notification issued

7a

Verification template and formula evaluation

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Not suitableSuitable

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Cosmetics Registration Requirements – Company documents

• Article of Association and its’ amendments• Deed of Establishment and its’ amendments• Domicile letter• Tax ID• Business License – stating cosmetics trading• Company Registration Certificate• Import License – which covers cosmetics product

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Cosmetics Registration Requirements –Product Documents

• Letter of Authorization (LoA) – from Principal to Distributor or Agent, shall be legalized by Indonesian Embassy in the origin country

• Certificate of Free Sales (CFS) from origin country – legalized by Indonesian Embassy in the origin country

• Good Manufacturing Procedure (GMP)• Certificate of Analysis – with detail % of each ingredients• Relationship Letter – if the Principal is different with the

Manufacturer

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• Food supplement registration in Indonesia takes around 3 - 6 months. The registration lifetime of food supplement is valid until 5 years as long as it is still meeting the prevailing provisions and extendable through re-registration of food supplement product.

Food Supplement Registration Timeframe

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Food Supplement Registration Process – Legal Entity Registration

Fill out legal entity online registration form

1

Verification process2

Facility inspection to the office and warehouse

3

4 5Submit legal entity documents and inspection report to BPOM

Data verification by BPOM

Returned to be corrected or completed

6bUser ID and password provided by email

IncompleteComplete

6a

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Food Supplement Registration Process – Product Registration


1

Submit product documents to BPOM

2

Pre-registration payment to BPOM

3

Verification of pre-registration payment

4

Pre-registration process

Request for additional data

6bRegistration payment to BPOM

6a

5IncompleteComplete

Verification of registration payment

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Evaluation of registration process

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Product registration number issued

Letter requesting additional data

Rejection letter

9b

9c

9a

Rejected

Incomplete

Approved

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Food Supplement Registration Requirements –

Company documents

• Article of Association and its’ amendments• Deed of Establishment and its’ amendments• Domicile letter• Tax ID• Business License – stating food supplement trading• Company Registration Certificate• Import License – which covers food supplement product

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Food Supplement Registration Requirements –Product Documents



• Good Manufacturing Procedure (GMP)• Relationship Letter – if the Principal is different with the

Manufacturer• Certificate of Analysis of finished product – with detail % of each

ingredients• Certificate of Analysis of each raw materials• Safety test certificate from authorized laboratory in Indonesia• Toxicity test, if the product safety is unknown

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• Medical devices registration in Indonesia takes around 3 - 6 months, according to the class of product. The registration lifetime of medical devices is until 5 years as long as still meeting the prevailing provisions and extendable through re-registration of medical devices product.

Medical Devices Registration Timeframe

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Medical Devices Product Registration


1

Verification of medical devices class

2

Payment to Ministry of Health

3

Evaluation I (according to the class)

4

Additional data (if required)

5

Evaluation III

Additional data (if required)

Evaluation II6

Incomplete Complete

Marketing Authorization Number issued

9a

8

7

Rejected to be completed

9b

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Medical Devices Registration Requirements – Company documents

• Article of Association and its’ amendments• Deed of Establishment and its’ amendments• Domicile letter• Tax ID• Business License – stating medical devices distributor• Company Registration Certificate• Import License – which covers medical devices product• Medical Distributor License (IPAK)

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Medical Devices Registration Requirements –Product Documents


• Power of Attorney (legalized by Indonesia embassy / consulate general in country origin)


• Good Manufacturing Procedure (GMP)• ISO 13485 and/or ISO 9001 or TUV, CE Certificate• Distribution agreement between distributor to company, and

company to manufacturer (short only)• Test report in detail and still valid • Quality control report of the production • Flow Chart or Standard Operation Procedure at Factory• Equipment material data, labelling, and lot/batch numbering system

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Medical Devices Registration Requirements –Product Documents

• Manual instruction in English and Indonesian (include explanation if any specific symbol)

• Procedures for maintenance of equipment in English and Indonesian• Brief marketing history in origin country• Post market evaluation (complaint handling, etc.)• Executive summary

– Brief review of medical device including function and how to use it mechanism

• Medical device description– Usage instruction– Brochure– Material product– Expiry information– Feature– Packaging specification & design

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Contents



Company Profile


Halal Certification

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Halal Certification• Halal certificate is issued by the Indonesian Council of

Ulama (MUI) based on assessment conducted by the Assessment Institute for Foods, Drugs, and Cosmetics The Indonesian Council of Ulama (LPPOM MUI).

• Government bodies responsible for food controlling:– Ministry of Agriculture for meat and animal based

foods– National Agency for food and drug control (BPOM) for

food packaged product• According to the regulations, it is mandatory to have Halal

certification for food supplement and cosmetics, however it has not been implemented yet until now and planning to be implemented by the year of 2017 or 2018.

.

For further info, visit: www.cekindo.com, email to: [email protected], phone: 021-80660999

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Halal Regulation and Timeframe

• Regulations regarding Halal Product Certification is based on Law No 33 of 2014.

• The halal certification process is taking time for 60-75 days after the documents complete.

• The validity period of halal certificate is 2 years and shall be extended 3 months prior to expiration date.Halal certificate issued by the

Indonesian Council of Ulama (MUI)

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Halal Certification Standard in Indonesia

For further info, visit: www.cekindo.com,email to: [email protected], phone: 021-80660999

http://www.cekindo.com/

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Halal Assurance System (HAS) in Indonesia

For further info, visit: www.cekindo.com,email to: [email protected], phone: 021-80660999

HAS is an integrated management system which is established, implemented, and maintained to manage materials, production processes, products, human resources, and procedures in order to maintain the sustainability of halal production process in accordance with LPPOM MUI requirements.

• HAS 23000: Requirements of Halal Certification• HAS 23103: Guidelines of Halal Assurance System Criteria of

Slaughterhouses• HAS 23201: Requirements of Halal Food Material• HAS 23101: Guidelines of Compliance the HAS Criteria in the

Processing Industry

http://www.cekindo.com/

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Halal Certification Procedure

Understand the requirements of halal certification and participate in the training for Halal Assurance System (HAS)

1

Implement Halal Assurance System (HAS)

2

Prepare Halal certification document

3

Register Halal certification (upload data)

4 Monitoring pre-audit and payment of contract certification

5

Obtain Halal certificate and HAS certificate

Fatwa commission meeting

Audit implementation6

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Halal certification is a process through a certain procedure to prove that the materials used, production facility, production process and halal assurance system of the producer have met halal requirement of LPPOM MUI.

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Contents



Company Profile


Halal Certification

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Our VisionTo be leading consulting firm of business services to clients expanding and operating in Indonesia.

Our Mission To provide full-range of market-entry and corporate services to enable our clients to focus on their core business and activities in Indonesia and beyond.

PT. Cekindo Bisnis Grup is a leading consulting firm of Market-Entry and Corporate secretarial services to clients expanding and operating in Indonesia and further to Southeast Asia.

Our ValuesClient-focusedExcellence performanceKnowledgable locallyIntegrity moralNormative operations standardsDelivered on-timeOne stop services provider

Company Profile

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Our main services:

Business Set Up

Business Process

Outsourcing

Local Representation

Company Registration

License & Product Registration

Market Research & Analysis

Local Partner Selection

Trade Mission Land & Property

Ownership

Recruitment & HR Establishment

Payroll Management

Accounting & Tax Reporting

Visa & Work Permit

Mystery Shopping

Local Distributor & Partner

Buying Agent Office Space

Cekindo Services

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Senior AdvisorProf. Dr. Rahardi Ramelan

Relevant Experience

Mr. Ramelan is currently Senior Advisor at PT Cekindo Bisnis Grup. Hi is a Research Professor at the Agency for the

Assessment and Application of Technology. The honorary degree of Doctor Honoris Causa from Monash

University, Australia and Northeastern University Boston.

Minister of State for Research and Technology of the Republic of Indonesia and Chairman of the Agency for Assessment and Application of Technology (BPPT) in the Seventh Development Cabinet of the Republic of Indonesia.

Minister of Industry and Trade in the Development Reforms Cabinet of the Republic of Indonesia and Chairman of National Logistic Agency.

Deputy Chairman for Industrial Analysis and Vice Chairman of the National Development Planning Agency of the Republic of Indonesia

Several management positions and responsibilities related to Indonesian Aviation industry, the Weapon industry.

Prof. Dr. Rahardi Ramelan

Profile Overview

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Principal ConsultantMichal Wasserbauer

Michal is currently Principal Consultant at PT Cekindo Bisnis Grup. He has more than 5 year‘s experience in the

Corporate Market research, Strategy and Evaluation Expansions, Business Consultancy, and Preparation of

Business Feasibility Studies. He has worked for various industries, namely Grocery and Marchandise Retail,

Energy, Medical Device, Heavy and Automation Industries.

+6281282300584 | [email protected]

Michal Wasserbauer

Market opportunities valuation Investment analysisPerformance management Feasibility studies

Strategy planningStakeholder managementMarketing consultancy

Profile Overview

Relevant Experience

Relevant Skills

Multinational grocery and general merchandise retailer: Capital Investment Appraisals

World‘s largest student and recent graduates-run organisation: Financial Controller

International consultation company: Market Expansion Consultant

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Principal ConsultantNurmia Agustina

Nurmia is currently Principal Consultant at PT Cekindo Bisnis Grup. She has wide experience in the areas of Business

Development, Legal Corporate Restrictions, Business Consulting, Project Management, Market Development &

Entry Strategy, Sales & Distribution, Management Strategy, Recruitment, Visa & Work Permit, and Change

Management. She has worked for various industries, namely Energy & Resources, Telecommunication, Retail,

Pharmaceutical & Medical, Financing, Non-Profit, IT and Heavy Industries.

+628119691987 | [email protected]

International Management company: Management & Legal consultant

Chamber of Commercial: Head of Business Processing Section

Nurmia Dwi Agustina

Corporate lawOutsourcing processesCompany formationAcquisitionsProject ManagementCompetitive Analysis

Business PlanningRisk ManagementTalent Management StrategyRecruitmentVisa & Work PermitChange Management

Relevant Experience

Relevant Skills

Profile Overview

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Selected Clients

PT. Cekindo Bisnis Grup

Grand Slipi Tower 9th floorJl. Letjend. S. Parman Kav 22-24Jakarta 11480Indonesia

[email protected] +6221 80660999

Cekindo regulatory for healthcare and wellness in indonesia

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Transcript of Cekindo regulatory for healthcare and wellness in indonesia