Project Consultancy Services

Project Consultancy Services

TSP provides complete project solution for Pharmaceutical Formulation and Bulk Drug Industries towards Compliance to Local and International Regulatory standards. It is managed by, proven best professional having wide experience of different types of pharma quality systems and its documentation. In competitive and quality environment, International level recognition has become needed for every company for the long run survival and growing company like you are looking for such opportunities

The companies responsible for the designing, commissioning, and optimizing of projects

Our Service includes Turnkey projects, project planning, project execution, Project validation and environment safety.

Our Core Competencies

• Concept: Plant layout; Man & material movement details; Preliminary architectural drawings; HVAC concepts; Utility specifications; Environmental & safety designs, etc.
• Planning: Architectural; Civil & structure; Electrical; Mechanical & Piping; HVAC; Utility; Atomization, etc.
• Commissioning & Validation: Master planning; Validation program; Protocol development; Process & material qualification; SOPs, etc.

Type of Industries & projects:

• Bulk drugs (Organics & In organics)
• Chemicals (Chemicals, Fertilizer & pesticides)
• Pharmaceuticals (OSD, Oral liquid, Topical, Injections, PFS, Patches)
• Medical devices (Orthopaedic implants, Surgical dressings, Contraceptives, Dental implants, Ophthalmic devices)
• Cosmetics, Herbal (Ayurvedic)
• Food Industries

The S.M Pharma Solution advantage:

• Single step consultancy for all concepts
• Cost effective designs
• Familiar with all guidelines
• Project planning as per scheduled timeline
• Post project support

Client challenges:

Challenges to successful S.M Pharma Solution adoption include the following:

• Periodic updating guideline knowledge
• Concept designing as per regulatory requirement

Services we offer:

Preparation and development of dossiers:

To comply with the international regulation, S.M Pharma Solution provides efficient timeline and flexible dossier services. We offer all kind of dossiers as per international regulations like CTD, eCTD, ACTD and all other country specific guidelines.

S.M Pharma Solution offers complete dossier preparation including below parts:

• Document preparation and dossier compilation
• Sample generation; From artwork designing to final registration samples with reference standard*
• Other documentation support like BA/BE, CT, etc.
• Support for legalization and notarization of documents.
  

Preparation and submission of Drug master file (DMF):

S.M Pharma Solution provides quality DMF preparation and submission services. We offer DMF preparation as per CTD format and having expertise in preparation of all type of DMFs like type I, II, III and IV.

We also provide DMF sourcing for various kinds of markets.

Preparation of site master file (SMF):

S.M Pharma Solution provides SMF preparation for all kind of facilities like Tablet, Capsule, Oral liquids, Injectables (Liquid, dry powder and lyophilized), Topical, Hormonal, Cytotoxic, APIs.

Product development reports:

For making your product developments more perfect S.M Pharma Solution provides preparation of product development reports as per enterprise and country requirements. We offer development reports to contract developers with premises and third party scale up support.

Process validation:

S.M Pharma Solution offers protocol and reports of process validation for commercial scale batches. Our expertise team also facilitate technical support to validate the methods and generation of process validation reports at customer premises.

The S.M Pharma Solution advantage:

• Single step consultancy for all regulatory services
• Confidentiality of the documents with CDA
• Cost effective regulatory support
• Round the clock regulatory support like In-house regulatory department
• Dossiers and DMfs in all guidelines
• Timely services
• Post submission and post registration support
• More priorities to query reply
• Re-registration support

Client challenges:

• Regulatory challenges to successful S.M Pharma Solution adoption include the following:
• Periodic training for updating guideline knowledge
• Cost per dossier
• Specific market experience

Licensing Services

We define “Licensing service” as certification tool that reliably empowers you to Research, manufacture and market your product safely and within regulations.
In licensing service S.M Pharma Solution helps you to get various kinds of certificates that will reconcile you to regulations.

Client challenges:

Licensing problems that call for licensing services:

• Periodic market updates
• Changes in requirements
• Lack of update after application
• No committed timeline

S.M Pharma Solution at DCGI:

• New drug approval
• Product registration in India (API, Finished formulations, Medical devices, Cosmetics, Vaccine & Biotech products)
• BE NOC
• Export & Import NOCs
• Test License NOC
• OTC approval
• Embassy attestation

S.M Pharma Solution at FSSAI:

• New product approval
• Existing product approval
• Conversion of existing license in to FSSAI
• Renewal of registration or licence
• Fresh FSSAI license
• Food import registration in India

S.M Pharma Solution at ISO:

• New ISO certification
• Renewal of certification
• ISO Guidance for compliance