Acute Research centre (ARC) is a full service provider in basic chemistry research, API development of first to file (FTF) & future generics molecules, cost effective commercial technology of existing API and Intermediates, CRAMS, synthesis and characterization of analytical standards/impurities and regulatory expertise for global markets along with cGMP support services.

The API development team focuses on novel chemistry including novel polymorph and process to provide our customers with possible early entry opportunities in various markets with help of our IP expertise.

Expertise in the developments of cost effective novel technologies of API / Intermediates free from Genotoxtic impurities and quality benchmarking in identical with innovators. Our experience of more than 35 yrs with patents and several publications worldwide. ARC team brings a depth knowledge and breadth of experience across drug substance/product development pathways, allowing us to address the full scope of a client’s regulatory and drug substance development needs and closely worked with various regulatory authorities.

Our Services

API Development

Analytical Development

CRAMS

Working Standards & Impurities

REGULATORY AFFAIRS MANEGMENT/cGMP SUPPORT SERVICES

Phytochemicals

Manufacturing Services & Tech Transfer

API Development


Few decisions in pharmaceutical operations are as critical as selecting the right API Development process. Acute Research, chemical development scientists have the skill and experience to meet a wide range of outsourcing needs from the custom synthesis and scale-up of an existing route, to identification and development of new manufacturing routes from scratch. At each step of the process development cycle, complete hazard assessment tools are available to allow for safe production of your compounds.

Custom Synthesis from Milligram to Kilogram

Scale-up of Existing Processes

Process Research, Development & Optimization

Large-Scale Synthesis & cGMP Commercial Manufacturing

Analytical Development


At any development stage and scale of synthesis, Acute services for contracted customers include all supporting activities that are required to be adequately cGMP compliant such as:

Analytical method development and validation

Process validation

Cleaning validation

Batch release

Characterization of solid state properties, (e.g. particle size distribution and polymorphism)

Proof of API structure

Identification of impurities

Preparation of Analytical Reference Standards

Conduction of stability studies

CRAMS


The growth in Development and Manufacturing Services is largely driven by the Chemical Development group. Our state-of- the-art ARC offers a one-stop destination for organizations/Customers looking to optimize their intermediate, API, phytochemicals without compromising on the quality of output.

We have reined our strengths through strong CRAMS team (Scientist, chemical engineers) with modern facilities, command over affordable technologies and gained experience of years by performing thereby continuously developing and nurturing desired quality products and technologies within the stipulated timelines.

CRAMs basically consists of the following two activities:

Custom synthesis

Contract manufacturing


Other Services (CRAMS)

FTE model (full time equivalent), for fixed tenure, on a mutually agreed target compound/processes.

Analytical method development and validation.

Supply of Impurity standards.

Polymorph evaluation.

Salt screening.

CRAMS also provides services in development of dossier for submission to regulatory bodies. This involves collation of information from the scientific publications and laboratories. Expertise by CRAMS in this case demonstrates excellent review of documents and clarity in communications with regulatory bodies.

The focus of compliances involves:

Compilation of Dossiers

Preparation of regulatory responses

Post approval regulatory changes

Working Standards & Impurities


Working Standards & Impurities Our synthetic and analytical team work in close coordination to develop process for Synthesis and characterisation of impurities by various spectrometric techniques.

Regulatory Affairs Management And CGMP Support


GMP COMPLIANCE FUNCTIONS:

Acute Research is a fastest growing GMP Compliance solutions provider globally, unique in terms of holistic GMP compliance offering of consulting and outsourcing solutions.

Acute Research is highly specialized with different Centre of Excellence for various GMP Compliance functions.

GMP Compliance Strategy and Consulting

  • Acute Research assists to provide strategy and action plan to facilitate the regulatory audits like USFDA, EUGMP, TGA etc.
  • To coordinate with regulatory agencies to collate of supporting documents required by regulatory agencies to process the audits, co-ordination for fees etc.
  • Hold interaction with regulatory agencies on behalf of clients companies.
  • Preparing the cover letter, application form as per clients request.

Gap analysis vs Practices

  • Acute Team has expertise to find out the gaps vs practices in QMS documentation.

Remedial measures on gap analysis

  • Acute Team has expertise to provide remedial measures on the gaps findings and implementation of various system

Facility audits

  • Acute team has expertise to audits the facility as per regulatory norms 21 CFR 211, 210, EU GMP, ICH Q7 etc.

Implementation of various policies and committees

  • Acute support to implement various important policies to support system deficiencies. Also assist to implement the policy on global CAPA in various facilities as an unique quality system.
  • Acute support to form various committees like ‘remediation measures monitoring committee, ‘a GMP resource advisory committee’ committee to monitor preventive maintenance programme activity and formation of GMP Compliance cell to monitor all activities related to GMP.

Intensive Training Programme on cGMP

  • Acute has expertise team to identify and conduct the GMP training as well as subject related training on continuous basis as the most important tool to overcome the GMP issues.

Product Risk Assessment & Global CAPA

  • Acute team assists to conduct the product risk assessment based on previous findings from the regulatory authorities. This will involve retrospective review of product quality data, manufacturing data, deviations, change control, out of specification (OOS), stability data and market complaints for last two years.
  • Acute assist to write Global CAPA and implement of the same in all manufacturing sites.

21 CFR compliance activities

  • We assist in 21 CFR compliant network software for chromatographic instruments and training of laboratory staff.
  • Installation and validation of 21 CFR part 11 compliant network software for all chromatographic instruments, this will help to archive the electronic data on a real time basis.

We provides end to end regulatory services for US, EU, Canada, India , Latin America , Asia , Middle East and other emerging markets.

505(b)(2) NDA , IND, ANDA , MAA filings.

Electronic CTD filings regulatory outsourcing services.

Coordinating Pre-IND Meetings and Scientific Advisory Meetings.

Responding Regulatory queries / deficiencies.

Drafting adequate responses for FDA-483 observations / warning letters.

Conducting Due Diligence Audits , Base Line GMP audits , Comprehensive systems audits , Risk based audits.

GMP training and support in development of good quality systems and good documentation practices.

21 CFR part 11 compliance management.

Phytochemicals


Phytochemicals Our team of phytochemical section is equipped with estimation, extraction, and isolation of key ingredients through various technologies including flash column technology.

Manufacturing Services & Tech Transfer


At ARC we have the capabilities to redefine the commercial process with respect to cost, ease of operation, capacity enhancement with control and EHS followed by Scale-up of Commercial Technology of API & Intermediates.