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    Regulatory Affairs  
  DMF/ DOSSIER IN CTD/ACTD FOR BULK DRUGS and DOSAGE FORMS FOR EXPORT REGISTRATION  
    BA- BIO AVAILABILITY STUDY REPORTS, BE- BIO EQUIVALENCE STUDY REPORTS  
       
   

Enrich Pharma provides quality services in regulatory affairs documentation namely Common Technical Document (CTD), Asian CTD (ACTD) for Product Registration Dossiers, Drug Master File (US DMF),European DMF (EDMF) for API's & Site Master File (SMF) & Plant Master file (PMF),

Also specialized in clinical research and medical consulting for medical device, pharmaceutical and biotechnological product development from phase I to phase IV for Indian and Multinational pharmaceutical companies in cost-effective manner.

Our team has a strong background in clinical research and pharmaceutical development. Our thorough understanding of the clinical and regulatory issues involved in clinical trials combined with our expertise in the outsourcing model will help our clients receive quality products on time and within budget.

We are listed as one of the most preeminent providers of Drug Regulatory Services in India. The Pharmaceutical Regulatory Services includes services for GMP, Drug Master File (DMF), Validation, Training and Documentation, Mock audits etc. as per regulatory requirements. It also includes CTD preparation, making all systems adhering to IR requirements and generation of technical data. The Pharmacy Regulatory Services offered by us are known for responsiveness, efficiency, strategy and for being personalized.

We provide services for cGMP, Drug Master File (DMF), Validation, Training and Documentation, Mock audits as per regulatory requirements, replies to deficiency letter by regulatory agency, CTD preparation, making all systems adhering to International Regulatory requirements & generation of technical data in line with the regulatory requirements and submission of dossiers for various country specific requirements managed by international level team.

Enrich pharma has tie-up with different Contract Research Organization and Pharmaceutical companies which offers services in all the phases of product development which includes Chemical/ Analytical research, Formulation development, Pre-clinical studies and Clinical Research.

We have Policy for all activities which make sure that we can offer right kind of services through right CRO/ Pharmaceutical Company with total confidentiality maintained.

 
       
    We provide services as below  
   
  Clinical Trials (Phase I - IV)
  Bioequivalence & Bioavailability Studies ( BE / BA Studies )
  Data Management
  Bioanalytical / Analytical Method Development & Validation
  Regulatory Affairs
 
       
   

Our allied CRO's which have many approvals like WHO/MCC/Turkey/US FDA etc., offers one of the best clinical facilities under one roof beginning with screening of volunteers and their selection, applying strict inclusion and exclusion criteria as per DCGI / ICH –GCP / USFDA guidelines or as per regulatory requirements.

Enrich Pharma focuses on serving small and medium size firms. We have the resources to provide One Stop Regulatory Affairs Solution for most of the countries and the experience to provide accurate and high quality services. Enrich Pharma provides its clients with a clear understanding of the regulations regulating the country and a clear plan to help achieving regulatory compliance.

For clients who wish to Export their products , we assist during all phases of product search, negotiation, registration , distributor , product launch, marketing and orders.

 
 
For Manufacturers/Suppliers.
Enrich Pharma's International Marketing Consultants can provide export advice, systems and on-site training tailored to your business needs, or we can manage a complete foreign marketing arm for your company.
OUR PRIME SUPPORTS ON EXCLUSIVE BASIS for Russia, All CIS countries, Middle East, Africa , Asia Pacific, USA and Latin American countries.
(please visit "Our Team" page for our strong hold Countries list.)
   
Our Services:
  We support the market survey and demand for your products for the registration.
  We support the products registrations in the Ministry of Health in the respective countries.
  We support to determine the current and future requirements of key distribution partners for your products.
  We prepare the sales plan for your products in coordination with your Purchase, Production, QA and R&D as required.
  We ensure internal communication related to System, Marketing activities and responsibilities down the line.
  We develop new markets / new customers for your product range.
  We take guarantee/assurance for your Payment Collections.
  We can identify potential collaborators for joint venture projects in the Indian sub continent and we can link the exciting Joint Venture proposal offers from
  many countries.(for oncology etc.,)
  We support to participate in tender business and follow ups till the payments.
  We set up a 'Direct Marketing Program' that gives you direct control of buyer relationships, service quality, logistics and communications; all facilitated by
  Enrich Pharma's to reduce your expenses.
  We support in getting orders for any requirements like API's Machinery, Chemicals, instruments, paramedical etc., from our overseas
  customers time to time.
  We support in preparation of Product registration dossiers for formulations in CTD/ACTD ,DMF for API's and Professional Translation Service
  (in all languages) for the drug registration dossiers /DMF's for registration in many countries.
   
 
 
For OVERSEAS Manufacturers/Suppliers.
In keeping with our vision of developing our capabilities as an integrated services company we offer International Companies a platform for entering the Indian market using us as their Agent or by working with them to set up their Branch Office in India so that their activities can be legitimately conducted and supported. We are already representing some of the MNC’s from Swizterland, Ukraine, Italy, Syria ,Egypt, Sri lanka , Yeman, Costarica etc.,