Stepup Pharmatech

Stepup Pharmatech Regulatory Service Freelancer The proper conduct of its Regulatory
Affairs activities is therefore of considerable economic importance for the company.

In today’s competitive environment the reduction of the time taken to reach the market is
critical to a product’s and hence the company’s success. Regulatory Affairs is a comparatively have been developed from the desire of governments to
protect public health by controlling the safety and efficacy of products in areas including pharm
aceuticals, veterinary medicines, medical devices, pesticides

, agrochemicals, cosmetics and
complementary medicines. The companies responsible for the discovery, testing, manufacture and marketing of these
products also want to ensure that they supply products that are safe and make a worthwhile
contribution to public health and welfare. Most companies, whether they are major multinational pharmaceutical corporations or small,
innovative biotechnology companies, have specialist departments of Regulatory Affairs
professionals – and those who don’t rely on the expert advice of independent regulatory
consultants to meet their obligations. Stepup keeps a track of the ever-changing legislation in all the regions in which the company
wishes to distribute its products. We also advise on the legal and scientific restraints and
requirements, and collect, collate and evaluate the scientific data their research and development
colleagues are generating.

17/01/2014

Dossier related
Dossier is a document file which have technical and administrative information.

Dossier as per CTD / ASEAN CTD / non-CTD (country specific guideline)

The Common Technical Document is divided into five modules:

Module 1. Administrative information and prescribing information
Module 2. Common Technical Document summaries (Overview and summary of modules 3 to 5)
Module 3. Quality
Module 4. Nonclinical Study Reports (toxicology studies)
Module 5. Clinical Study Reports (clinical studies)

Common Technical Document for ASEAN countries contains of four parts:
Part I: Administrative information
Part II: Quality
Part III: Nonclinical Study Reports
Part IV: Clinical Study Reports

We offer these services for:- Asian, African and CIS markets

Our services:-
Advising on suitable regulatory strategy
suggesting the finest route to the market
sketch up project plans
Monitoring the project till product registration

Analytical Services

Our Analytical Services:-
Product Analysis (as per USP/BP/IP/IHS)
Analytical Method Development
Analytical method validation, dissolution and stability studies (as per ICH)
Finished products or intermediate product sample testing

Analytical Documentation work:-
Drafting active - specification, certificate of analysis and method of analysis
Drafting non-active - specification, certificate of analysis and method of analysis
Drafting packing material - specification, certificate of analysis and method of analysis
Drafting pre-formulation, BMR, MFR, process validation, method validation, stability studies documents
Product registration assistance
Product development assistance


Contract Services
• Formulation Product Development
• Analytical Development and Validation
• Process Validation
• Stability Studies
• Dossier Compilation
• Finished product supplies from approved facility
Product registration

Step-Up Pharmatech assist manufacturer / applicant during product registration for:

Dossier compilation
Dossier preparation
Dossier Review
Application Drafting
Handling MOH queries
Draft query reply
Advice on Registration Management
Pack insert / PIL drafting
SMPC Drafting
Document (technical) preparation
Product literature
Product Literature & Readability Testing

Step-Up Pharmatech prepares high-quality finished product literature for regulatory approval. We also review the same.

We provide this service for:
Summaries of Product Characteristics
Patient Information Leaflets
Labelling texts

Address

Ahmedabad
380014

Opening Hours

Monday 9am - 7pm
Tuesday 9am - 7am
Wednesday 9am - 7am
Thursday 9am - 7pm
Friday 9am - 7pm
Saturday 9am - 7pm

Telephone

9099026353

Website

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