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We are offering solutions to handle projects for the pharmaceutical and drug formulation industries according to the set national as well as international standards. Our highly skilled professionals have wide experience in the project management for different various quality systems that helps you to maintain a competitive and quality environment. For the survival and continuous growth of the company the certification and documentation of the international levels are necessary that are also provided by our company. We are also responsible for handling of the turnkey project planning, validation, execution and safety to maintain the optimality of the project.
Our Core Competencies
For the stability and survival of the project we are highly towards the three main regions such as concept, planning, and commissioning. These factors allow us to create a stabilized systems which deals with all the competitive area such as plant layout, utility specification, heat ventilation and air conditioning concepts, man & material movement, master planning, SOPs, validation program, process and material qualification.
Type of Industries & projects:
We are capable to provide consultancy services in different industrial sectors that are given below:
· Organic/Inorganic drugs,
· Medical device and equipment manufacturing such as ophthalmic devices, surgical dressing and more.
· Pharmaceuticals (OSD, Oral liquid, Topical, Injections),
· Chemicals,
· Herbal/Non-Herbal cosmetics,
· Food and beverage.
The S.M Pharma Solution advantage:
The single step consultancy offered by us helps to deal all concepts to provide the reliable guidelines to our clients for the scheduled project planning with post project support. We are familiar with all the local and international guidelines for the cost effectiveness and smooth operational stability. S.M Pharma have established a global leadership for the integrated services across the spectrum of commercial manufacturing of drug substances and products from our global network. We also provide post submission and post registration.
Client challenges:
The ultimate goal of our company is to assist our valuable customers dealing in various pharma and biotech projects to improve the life of patients. For the complete and successful adoption of the Pharma solutions customers must have to go through:
· Periodically updation of the guideline knowledge, and
· Designing of the system as per the set standards that has to be maintained as per the rules.
SERVICES WE OFFER:
From start to end processing we offers various different services for the optimality and efficiency of systems which includes dossiers preparation, submission master files, product development reports and process validation.
Preparation and development of dossiers:
The offered dossiers are available in different forms as per the international and country specific regulations such as CTD, eCTD, ACTD and many more. The preparation of the documents includes the following parts:
Dossier compilation,
Sample generation with reference standard,
Documentation support like BA/BE, CT, etc.
Valid legalization and notarization of documents.
Preparation of Drug master file (DMF) and Product development reports:
Our company provides quality DMF preparation as per CTD format for various kinds of markets and also provides SMF preparation for all kind of facilities like tablet, capsule, topical, hormonal, cytotoxic oral liquids, injectables and APIs. The development reports allow you to contract developers with premises and third party scale up support.
Process validation:
For the commercial scale batching of we design protocol reports which ensures validation of the system to provide technical support to validate the generation of process at customer premises.
LICENSING SERVICES
S.M Pharma provides licensing services as a certification tool that empowers your research, production and marketing of the produced pharmaceutical products with high safety and within regulations. These certifications will help you to get many different kind of certificates that will reconcile you to regulations.
Client challenges:
We are also dealing to provide consultancy services to help out our customers to handle licensing problems as per the market updates, updating after application, changes in requirement with adjustable timelines.
S.M Pharma Solution at DCGI:
Get services as per the set regulatory terms to get
New drug approval,
product registration in India,
Export & Import NOCs,
OTC approval,
Test License NOC, and
Embassy attestation to maintain the fluidity within the business.
S.M Pharma Solution at FSSAI:
For those clients that are dealing in food and beverage, contact us to easily get the new or existing product approval, fresh FSSAI license, food import registration in India, conversion of existing license in to FSSAI as well as renewal of registration or license.
S.M Pharma Solution at ISO:
For the validity and growth of the company we also offer services to deal with:
· New ISO certification,
· Renewal of certification,
· ISO Guidance for compliance.
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