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Crimson Consultancy

CRIMSON CONSULTANCY

Crimson is a clinical research consulting and Training company based in India. Crimson has been conceived with a primary focus on providing the highest quality service to pharmaceutical, biotechnology and devices industries for conducting research in India.

With the increasing number of clinical trials required for the discovery and development of new drugs, it has become imperative that pharmaceutical and biotechnology companies pass their product through the testing and regulatory process in rapid and cost effective manner. These companies are relying on contract research organizations (CRO’s) to provide the services that can bring their therapeutics first to market.

Contract Research organization (CRO’s), providing various services to pharmaceutical Industry are well established all over the world and are on a expansion mode in India. CRO’s are specialized in fields such as: Pre-Clinical ( Toxicology& Pharmacology), bioequivalence, Clinical and Pharmacokinetics, Clinical Trials ( Phase I-IV), Data Management, Formulation Development, Analytical Development and Regulatory Support .

Whether the outsourcing need are short or long term, Crimson provides a significant range of clinical trial related services for companies for using India’s potential strength on cost saving and helping toachieve quality in this area as per required domestic and international regulatory guidelines.

Crimson consultancy can work independently or function as an extension of the client’s existing management structure to maximize efficiency.

At Crimson the consultants are experienced Directors with a wealth of experience of more than 25 years. They have worked closely with various segments of the pharmaceutical, biotechnology, device. laboratory and CRO's industries and are well aware of the needs of the regulatory bodies world over.

The Directors are professionals and have a successful track record of executing and managing Phase I-IV multicenteric trials all over India and Asians countries . They have experience of having conducted more than 500 Monitoring Bioequivalence Studies for domestic and international regulatory submissions both in the area of clinical research and Monitoring Bioequivalence Studies. They have cleared each and every sponsor's and regulatory audits such as EMEA, MHRA, ANVISA, and US FDA under their leadership.

Crimson will advise and assists its clients on conducting feasibility and managing clinical research projects which also includes all the regulatory help. Crimson can help your company avoid potential administrative errors and pitfalls that can cause you ethical and regulatory issues including saving on time and money.

Crimson will therefore continuously monitor the CRO's and study sites and also the regulatory environments so that it adheres to all domestic and regulatory norms .

Our efficiency in providing quality services also stems from the fact that we have a very strong experienced scientific advisory board.

We have the pride in saying “Our Commitment, your advantage” and we will stand with you at every Phase of Drug Development both for New Molecular Entities as well as Generic Drug Development.

We will accept to service the following :

  • Feasibility and management of clinical research projects including pharmacovigalence in India for the sponsors.
  • Retainership by International Companies/ co-operates as Indian Representatives for negotiating, managing and monitoring and auditing their Research work in India.
  • We will undertake Quality Assurance and audit of your Clinical research and BA/BE activities including formulation contract development with India companies or CRO's.
  • We will undertake setting up Setups such as BA/BE and phase I units in India or in developing companies along with advising on quality systems for pathology and analytical laboratories and CRO's.
  • With the rich experience of our directors we will also undertake Independent Clinical as well as Bioanalytical monitoring of BA/BE projects of the sponsors for both domestic and International companies.
  • We will for Generic formulation development manage ,coordinate and stand responsible conduct of your pilot and Pivotal BA/BE projects.
  • We will also undertake Corporate training of professionals in CRO's for BA/BE and clinical trials which comes as a natural complement to develop competence in the area of our work experience .
  • We are most competent to handle Regulatory Affairs in India, as the Di rectors have always been associated with formation of Regulatory guidelines in India from the inception.

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