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Indian Regulatory Services

Pammvi Consultancy Services Limited assists customers in providing regulatory solutions and with knowledge base, professionalism and unquestionable ethics. It offers regulatory solutions to pharma, food, cosmetic, medical devices, nutraceuticals, biological & vaccines industries. We Have a team of associates who are experienced managers and experts in relevant consultancy services.

Pammvi Consultancy Services Limited offers through its associates a complete range of regulatory consulting services to the Healthcare industry.

We Cater to Various Industries mentioned below,

Pharmaceutical Formulation
Pharmaceutical APIs / Bulk drugs
Nutraceuticals
Herbal
Ayurveda
Cosmetic
Veterinary
Biotech

Our customized approach combines deep insight into the dynamics of companies with close collaboration at all levels of the client organization. We deliver quality work to our clients keeping in mind their special interests .

We measure our success by our clients success and make our resources available to them. We seek to identify their needs, not just deliver good work.

rbi fema consultant

Services offered CDSCO Consultant

Our experienced associates are familiar with all aspects of medical device regulatory compliance in India. Our services include obtaining Manufacturing License for medical devices in Form-28, medical device registration & approval for foreign manufacturers in Form 41 and import licenses in Form 10.

Manufacturing License in form 28 (For Indian Manufacturer)
Providing guidance to develop your manufacturing premises as per Schedule M
Preparation of complete document.
Preparation and submission of application to CDSCO, Zonal and state drug controlling authorities.
Providing complete support during inspection and audit.

Medical Device Registration Certificate in Form 41 (For Foreign Manufacturer)

Determine your device fits or not into the list of notified Medical Devices regulated under Drugs and Cosmetics Act, 1940; and Rules, 1945.
Coordinate the device registration and approval process with Indian Medical Device Regulators (DCG(I)/CDSCO)
Preparation of all necessary documents for the product registration application including Forms 40.
Suggesting appointing an Indian Agent as your official representative.
Submission of Site Master File and Device Master File as needed.
Coordinate with the DCG(I)/CDSCO to address follow up questions and monitor progress.


Import License in Form 10
Determine your device fits or not into the list of notified Medical Devices regulated under Drugs and Cosmetics Act, 1940; and Rules, 1945.
Coordinate with Indian Medical Device Regulators (DCG(I)/CDSCO).
Preparation of all necessary documents for submission of application.
Suggesting appointing an Indian Agent as your official representative.
Submission of Site Master File and Device Master File as needed.
Coordinate with the DCG(I)/CDSCO to address follow up questions and monitor progress.


Other Services include

  1. New Drug Approvals
  2. FDC Approvals
  3. Import Registration
  4. GLobal Clinical trials
  5. BA/BE NOC
  6. Post Approvals
  7. Cosmetics Import registration

RESEARCH DESIGNS AND STANDARDS ORGANISATION (RDSO)

Pammvi Consultancy has started its journey in the year 1996 with a philosophy of sharing knowledge and bridging the gap for tomorrow’s success. In this present scenario of shrinking global economy, many organizations have been bound to cut their expenditure to keep them on track. At the same time they cannot negotiate with their existing quality level rather sometime they need to opt for a better quality level. It is needed but also unjustified to employ specialist people for year on year as they drain out a hand some money after putting a little effort. Now what an organization can do? The answer is very simple you share your pain with us, no need to pay for all the time, pay for what you want. We care for our clients with utmost sincerity and provide guidance to the organization for implementing, management systems and obtaining product approval from RDSO. It is managed by skilled and vibrant associates who have enormous knowledge and experience toward industries manufacturing industrial products.

MANAGEMENT SYSTEM CERTIFICATION:

Every organization wants to demonstrate its ability to consistently provide products and services that meet customer and other applicable statutory and regulatory requirements and aims to enhance customer satisfaction through effective application of system including process for improvements and assurance of conformity. Apart from that they need to take into considerations external & internal issues and need and expectation of relevant interested parties and to promote risk based thinking in order to sustain in this competitive market.

PRODUCT APPROVAL/CERTIFICATION:

Our associates have experience towards product approval from RDSO (Govt. Of India).

THIRD PARTY INSPECTION SERVICE:

We have extended our hands towards aiding organization that are in need to get their products inspected and cleared, those are conforming requirements, which in term would help them to receiving clearance from the customer. Several items including various types of equipments (heavy, medium and light) is being handled We care for our clients, feel their pain and provide best possible solution so that they can have a smooth path ahead.

Services-

Follow up for various approvals required from RDSO for indian railways.




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