Research & Development
Fidelity Life Sciences aspires to become one of the leading players in the global generic market. The foundation of this goal is visible in the range of talent and diversified expertise of its scientific team.
This Research and Development unit at Baddi (HP) is an integrated facility to provide pertinent opportunities for improving the patient health through developing formulated products. The R&D unit works to develop cost effective generic formulations that are bioequivalent to the originator product. The goal of R&D is to take advantage of all filing opportunities by doing effective product selection and patent landscaping. R&D unit, Located at Pune has in-house capabilities to conduct Bio-equivalent studies in its state-of-the-art Clinical Research Unit (CRU). R&D team is committed to deliver a comprehensive catalog of prospects for filing of registration dossiers, to ensure timely and successful product launches.
We have following specialized research & laboratories and focus onFormulation Development
The objective of Formulation Development is to deal with all the aspects of Generic drug development from pre-formulation to various regulatory and IP strategies with emphasis on timely development of formulations for dossier submissions. The focus of the department will be to develop high quality generic products for global markets for a fast and smooth registration process and timely approval.
High quality, technology driven product development is carried out to produce a stable and clinically safe and effective formulations. A variety of dosage forms are being developed as Tablets (conventional, chewable dispersible, orally dissolving, extended release, enteric coated etc.), Capsules, Semi-solids (ointment, cream, gel, lotion) and Liquids (solution, suspension). We also plan to tap the First to File (FTF), Paragraph II, III & IV and 505(b) 2 opportunities and extended Release products for ANDA as well as EU dossier submissions
Analytical Research Development
The Analytical Research Laboratory is the central analytical facility to support the development of the Generic Drug Products for various markets. The Central Instrumentation facility is equipped with modern scientific equipment to develop and validate methods of testing the quality of developed products as per national / international standards and regulations which includes:
Following are the activities carried in this department:
The analytical team is responsible for transfer of analytical methods and specification to various manufacturing site during the scale of the process Technology from R&D to commercial manufacturing of the Drug Substance and Drug Products. Department also provides various scientific in puts in handling the regulatory agencies.
Clinical Research & Pharmacokinetics
Clinical Research Unit [CRU]Fidelity Group has a Clinical Research Unit to conduct human volunteer bioavailability / bioequivalence studies as a part of its regulatory submissions to countries including the United States, European Union and rest of the world markets. Located at Pune, the CRU is spread across an area of 15,000 sq. ft. and can now house 42 volunteers participating in clinical studies. Clinical studies conducted at the CRU are in compliance with established operating procedures and regulatory guidelines of various regulatory bodies which include the Drugs Controller General of India [DCGI], the US FDA, ANVISA [Brazil] and the UK MHRA, as well as national and international ethical guidelines including the Indian Council of Medical Research [ICMR], the ICH GCP and the WHO. All the study projects undertaken at the centre are reviewed and approved by an Independent Ethics Committee as per the DCGI guidelines. The CRU provides fully air-conditioned, hygienic staying and recreation facilities for volunteers participating in the studies. It is also well equipped to handle any medical emergency in its intensive care unit and employs the necessary personnel with required qualification to assist in its various associated functions. Additionally, it has required medical specialists on call to attend to any medical emergency.
The Pharmacokinetic division is dedicated in providing leading edge innovative bio-analytical and pharmacokinetic solutions. The strong scientific and regulatory knowledge combined with expertise in bio-analytical method development and experienced scientists who understand the organizational needs for timely and accurate communication allows the Pharmacokinetic division to offer extensive bio-analytical, pharmacokinetic and statistical services.
The State of the art Pharmacokinetics division is equipped with sophisticated instruments like LC-MS/MS and HPLCs. The Laboratory operates in the GLP compliant environment to develop and validate the bio-analytical methods for drugs and/or there metabolites in human biological matrix. These validated assays are used for the quantification of the drugs and/or there metabolites from the clinical study samples of the Bio-equivalence (BE) studies. Specific QA procedures govern all activities from sample receipt through data packaging and sample disposal.
The studies performed at the Pharmacokinetic division are in compliance with the standard operating procedures and regulatory guidelines of various regulatory bodies which include the US FDA, ANVISA [Brazil] and the EMEA.
Pharmacokinetics and statistical analysis, sample size estimation etc is done using software tools like SAS® and WinNonlin®.
The facility is audited and approved by regulatory agencies like DCGI (India) for conducting Bioavailability and Bioequivalence studies in human volunteers.