SERVICES

We offer a wide range of services that includes

1. Regulatory licensing consultancy service (Manufacturing licensing on form 25 and 28, Sale and stock license on 20B and 21 B), Test License on form 29.

2. Statutory Licensing consultancy service (NOC from Pollution Control Board, Labour License, Factory License, ESI registration, PF registration, DIC I and II, Service tax, Sale Tax, Income tax, Excise registration).

3. Quality Systems Implementation service.

4. Environmental Systems Implementation service.

5. ISO 9001, ISO13485, ISO 17025 (NABL), ISO 14001, OHSAS 18001, ISO 22000, ISO 27001, TS 16949, SA 8000, Kosher, Halal (HAS 23000) and CE Certification consultancy service.

6. Product development for In-Vitro Diagnostics

Biochemistry (15 products)

1. Powder/Liquid stable

1.1 Alkaline Phosphatase (pNPP)
1.2 Glucose (GOD/POD)
1.3 Urea (Berthelot)

2. Liquid stable

2.1 Creatinine (Single Reagent)- Alkaline Picrate
2.2 Amylase (CNP-G3)
2.3 Creatinine (Double reagent)- Alkaline Picrate
2.4 Bilirubin T and D (J and G)
2.5 Calcium (Arsenazo)
2.6 Cholesterol with HDL (CHOD/POD)
2.7 Glucose (GOD/POD)
2.8 Triglycerides LS (GOP)
2.9 Uric Acid LS (Uricase)
2.10 Hemoglobin (End Point)
2.11 Total Protein (Biuret method)
2.12 Albumin (BCG method)

Immunology (16 products)

1. HBsAg ELISA (3rd Generation)
2. HCV ELISA (3rd Generation)
3. HIV 1/2 ELISA (3rd Generation)
4. HBsAg Rapid Card
5. HCV Rapid Card
6. HIV 1/2 Rapid Card
7. Syphilis Rapid Card
8. Malaria Pv/Pf Rapid Card
9. Malaria PAN/Pf Rapid Card
10. Malaria PAN Rapid Card
11. Malaria Pf Rapid Card
12. Dengue IgG/IgM Rapid Card
13. Dengue IgG/IgM/NS1 Rapid Card
14. Troponin I Rapid Card
15. Typhoid IgM Rapid Card
16. Leptospira IgM Rapid Card
17. hCG Rapid Card

Haematology (4 instruments).

1. Mindray BC-2800 (3 Part diff.) Haematology Analyser (5 Reagents)
2. Mindray BC-3200 (3 Part diff.) Haematology Analyser (5 Reagents)
3. Rayto RT 7600 (3 Part diff.) Haematology Analyser (3 Reagents)
4. Sysmex KX-21 (3 Part diff.) Haematology Analyser (3 Reagents)

7. Audit and audit preparation

ISO, CE, GMP, GLP, NABL

8. Document preparation

QMSP- Quality Management System Procedure (STS, STP, SOP)

Quality Manual

Site Master File

Project reports

Validation Master Plan

Device Master file

Technical Files

Dossiers-CTD/eCTD

Qualifications/Validations

9. Training (Quality Management System and Environmental Management System).

Good Manufacturing Practice (GMP)

Good Documentation Practice (GDP)

Good Laboratory Practice (GLP)

Good Warehousing Practice (GWP)

Good Engineering Practice (GEP)

Concept of QA & QC

Calibration & Validation

Clean Room Cleaning & Sanitization

Self Inspection & Quality Audits

Waste Control & Disposal

Gowning procedure and Personal hygiene in clean rooms

Vendor audit/qualification

Corrective Acton and Preventive Action

Change Control

Environmental Monitoring

Handling, storage, packaging, protection, safety & delivery of material

Identification and traceability

Handling Deviations

Handling Non-conformances

ISO 9001

ISO 14001

ISO 13485

CE mark

ISI Mark

5'S implementation

10. Facility Designing & Commissioning

Drug Products Manufacturing Facility (Sterile & Non Sterile

Testing Labs NABL & GLP

Clean rooms

ETP & STPs

Lab & Production Autoclave

Pure Steam Generators

Production Equipment

Medical Devices Manufacturing (Sterile & Non Sterile)

Calibration Labs as per NABL

HVAC Systems

Water Systems

Stability Chambers

Compressed Air Systems

Lab Equipment/ Instruments

11. Formation of Companies

Formation of Private limited Companies.

Formation of Public limited Companies.

Formation of non-profit association/ Sec.25 companies.

Conversion of Proprietorship concern, Partnership firm into Private or

Public limited Companies.

Conversion of Private limited into Public Limited and vice versa.

12. Formation of LLPs

Limited Liability Partnership (LLP) is a new form of organization introduced in India through the enactment of Limited Liability Partnership Act, 2008. Partnerships can now be incorporated as a limited liability partnership (LLP) and by doing so they can remove the unlimited liability of individual partners.

LLP is in vogue in many of the foreign countries like United Kingdom, United States of America, Australia, and Singapore etc. It is popular there, because of its dual characteristics, i.e., it is the blend of both the Company form and the Partnership form of organisations.

13. Company Law and Secretarial Compliances

Compliance relating to the meetings of Board of Directors, Shareholders, Creditors etc.,

Filing of Annual returns with the Ministry of Corporate Affairs and related legal documentation.

Maintenance of Minutes books, Statutory registers and other support services.

Compliances relating to statutory meeting and statutory report.

Changing/alteration in the name of company.

Changing the Authorised Capital and paid up capital.

Issue / allotment of shares and related compliances.

Transfer of Shares from and between Indians, NRIs and foreign persons.

Change of registered office within the same city, from one city to another and one state to another.

Alteration of main object of the company.

Starting new business given in the "Other Objects".

Inclusion of new business in the memorandum of the company.

Appointment & Resignation of Directors.

Appointment of directors and their remuneration.

Inter corporate investments and loans.

Advising on creation, satisfaction and registration of charges.

Drafting of Director's Report, Corporate Governance Report, Annual Report.

Matters related to Investor Grievances.

Payment of dividend and related compliances.

Change of management, take-over of management and related due diligence services.

Winding-up of companies / Striking off of the companies.

Director Identification Number (DIN) Compliance process as per DIN Rules 2006.

Secretarial Compliance Audit

Company and Secretarial law issues relating to holding of meetings, maintenance / filing of records, returns, corporate governance, ESOP, Buy Back of securities, Take-over regulations and Insider Regulations.

14. Statutory Certification

Statutory Declaration in Form 1 for Incorporation of new company in India.

Verification of declaration in Form 19, 20 and 20A for compliances to commencement of business / es.

Signing of Annual Return of Private / Public / Listed companies

Certify compliance of requirement under Schedule XIII

Certify all documents to be filed with Registrar of Companies to take on record within 10 days.

Issue of Compliance Certificate as to whether the company has complied with all the provisions of Companies Act, 1956 for all types of companies including u/s. 383A.

Declaration for registration of Memorandum and Articles of Section 25 companies.

Certify extinguishments and physical destruction of share certificates bought back by company.

Certify From 1 and 2 under Investor Education and Protection Fund Rules.

Certify allotment as approved by Stock Exchange.

Certify issue of certificates within one month of lodgment.

15. Compliance and Secretarial audit

We conduct compliance and secretarial audit for and on behalf of the corporate. It helps strengthen the Corporate Governance in an organization.

Compliance audit assists the Audit Committee and the Board of Directors on understanding the status of the statutory compliances, internal control systems, management information systems and its effectiveness in the proper and transparent governance of the organization.

16. Legal Due Diligence

"Due diligence" is a process of acquiring objective and reliable information, generally on a person or a company, prior to a specific event or decision. It is usually a structured, systematic research effort, which is used to gather the critical facts and descriptive information (or to determine an absence of significant negative factors) which are most relevant to the making of an informed decision on a matter of importance.

One growing usage of due diligence services is for assessing risks and checking facts associated with private stock subscription offerings available to qualified investors under Private Placement Memorandums, and similar investment opportunities.

In order to effectively perform due diligence, one must have an understanding of what really matters with respect to the decision at hand. Often, this requires an understanding of competitive industry landscapes, the customer market place, operations, financial aspects, business development, strategy, and business analysis. Without this kind of experience and understanding, it is difficult to go beyond the standard check lists, and to truly know what may be significant what the significant risks specific to this situation may be, what to look for, what to ask, and whom to question.

Due diligence is often associated with corporate acquisitions. Indeed, it is not only an essential step in any significant business acquisition, it can sometimes be the most important step.

Due diligence can also be useful, in a similar manner, in the overall assess-ment of a contemplated business deal (which, of course, can be significant even if it doesn't involve an actual acquisition). Likewise, due diligence is sometimes very appropriate in terms of learning more about a particular company. For example, a prospective board member or senior executive will want to know quite a bit about a company that has just extended an offer of a board seat or an executive position. This informa-tion needs to be comprehensive in covering critical factors, as well as objec-tive, so one does not want to rely entirely on that which is provided by the company itself.

17. Export and Import registration

18. Shop and establishment registrations

19. Qualifications and validations

Qualifications: URS, FAT, SAT, DQ, IQ, OQ, PQ

1 Facility
2 Equipment's
3 HVAC System
4 Water Generation & Distribution System
5 Compressed Air System
6 ETP/ STP
7 Steam generation & distribution system

Validations

1. Process Validations
2. Cleaning Validations
3. Analytical Method Validation
4. Media Fill Validation
5. Computer System Validation
6. Clean Room Validation
7. Compressed Air Validation
8. Water System Validation
9. Temperature mapping

20. EU representative services

A European Authorised Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives.

Regulation of goods produced by manufactures outside of the European Union, especially in the medical devices industry, instigated the need for Authorised Representatives. As clarified in the Medical Devices Directive amendment (93/42/EEC), it is required that alongside the CE mark all products must also have an Authorised Representative. As stated in this amendment, an Authorised Representative should serve as a contact point with the EU member states competent authorities.

An E.A.R. holds the responsibility to act as a neutral party between the competent authorities and the non EU manufacturers. They must ensure the manufacturer's compliance with the conformity assessment procedure set out in the European directives which apply to the manufacture's product. The EAR must uphold dual accountability with the manufactures if problems or questions arise regarding the product. The E.A.R. must provide their contact information for the manufacturer to place on the products, allowing the E.A.R. to be the primary contact for EU authorities.

An E.A.R. observes the manufacturer's compliance with the conformity assessment procedure set out in the European directives which apply to the product

.

They ensure the law is met by having Class I medical devices registered with the Competent Authorities before being placed on the market

.

They ensure their contact information is available to the manufactures to be placed on all the products they are representing, thus acting as a primary contact for the EU Authorities.

They must notify EU Authorities of all major incidents pertaining to products.

An E.A.R. must understand all EU regulations from each of the EU member states as well as the four European Free Trade Association (EFTA) states, and provide notification of changes and amendments to directives that affect individual products.

They must keep the product's technical file available at any time for the EU member states authorities and maintain confidentiality with manufacturer's sensitive product information, releasing them only to the appropriate authorities when called upon.