INDIA REGULATORY SERVICES

The journey from the birth of a concept to the approval of a product is a difficult one especially when faced with tough regulations. pharmxl offers a cost effective method to make this journey smooth and easy. Our knowledge of the laws and regulations pertaining to the development, testing, approval, manufacturing, commercialization and post-marking surveillance of a product provides you a good vantage point. Our focus is to acquire speedy approvals to enable clients achieve their objective of a timely and successful product launch.


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ENTRY TO INDIA MARKET

We offer strategic planning services during product registration in addition to finding distributors and acting as an authorized agent in India. With our knowledge of the Indian regulatory scenario and its intricacies, we can help you achieve your goal without any hindrances. Our experienced team is well aware of all the formal and informal processes to be fulfilled on the path to complete approval and launch in the Indian market. Our hand in glove approach ensures that at no point you find yourself battling with any process by yourself.



Regulatory Intelligence and Strategy

We at pharmxl will be with you throughout your journey. Our strategies are planned and executed by professionals who will aid you throughout the process starting from dossier preparation, product test support, registration of product and even post registration changes

Authorized Agent / Registration Holder Support

Global manufacturers without representation in India can appoint an authorized agent with a valid drug wholesale license to register their products. We at pharmxl can act as an authorized agent on your behalf to speed up the approvals and registration processes which accelerates your regulatory process leading to a quicker market entry.

Distributor Identification

The professional relationships we have forged over the years will help you find distributors in India with absolute ease.

Distribution Point

We act as a stock point for international companies providing end-to-end services for import, clearance and warehousing of the products using strong networking with logistic companies ensuring timely availability to distributors in India.

Our Services



OUR ADDITIONAL SERVICES

500

Solutions

1500

Solutions

800

Solutions

2500

Solutions

GLOBAL REGULATORY SERVICES

Entering into the vast realm of pharmaceutical products in international markets of EU, USA and other emerging ones like African subcontinent, requiresa comprehensive understanding of complicated regulatory requirements. At pharmxl, we ease the process of seeking swift approval for your products by defining country specific regulatory strategies right at the nascent stage of product development, eliminating potential roadblocks and ironing out any kinks en-route to a successful product launch.




Strategy Planning

The ACPL team puts together a time tested regulatory strategy, customized to your specific requirement that identifies and mitigates potential challenges in order to obtain approval for EU, USA and Emerging Markets. The team defines Clinical (CT/BA-BE, Published information, RLD/Comparator suggestion), Non-clinical (pre-clinical/Tox data) and Technical requirements (API and Drug Product specification & advise, Stability data, evaluation and proposed shelf life,) and helps in developing a quality product dossier. Furthermore, a country specific product strategy is developed. All these efforts are with one sole intent, 100% client satisfaction.

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Pre-Registration

  1. Data Generation and Data Review w.r.t Drug Substance and Drug Product DMF
    • Development & Preparation of R&D documents
    • Dissolution Comparative Studies Designing and Data Report
    • AM development and Validation as per ICH Q2A, Q2B
    • BA/BE studies
    • Reference Listed Drug (RLD)/Innovator Product/Comparator
  2. Regulatory & Quality Compliance Services & Expert Reports
    • GMP Audits/Site Due Diligence- API Site, FP Sites, Manufacturing Sites
    • Gap analysis on the Existing documents/data/dossier and conversion to country specific/ACTD to CTD and vice versa
    • Guidance & assistance on generation of data for successful submission of the Dossier to Country MOH/Health authorities.

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Registration

DMF (CTD format) Preparation, Review and Submission Dossier Writing and Review Dossier Registration: Submission to various regulatory agencies worldwide Handling of query Responses

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Post-Approval Changes

ACPL provides post-approval services which include carrying out product re-registration is well ahead of time. Renewal of Site GNP is also carried out according to schedule. Services also include renewal of BE center GCP certification and submission of Annual Product Review Submission to the concerned health authority. The complete life cycle of the product is planned and executed by ACPL.

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Regulatory Submissions

DMF, GENERICS, IND/CTA/NDA, Pre-IND meetings / Scientific Advice meetings, Pre-NDA meetings

Quality and Compliances

API, Formulations, Co-ordination with Regulatory Agencies & final response to CAPA; GLP & GCP at Toxicity Centre(s) and CRO respectively.

Markets

Regulated Markets U.S.A, Europe, Canada, South Africa, Australia, NZ, etc Semi Regulated Markets ASEAN, CIS, Middle East, Africa, LATAM (Brazil, Mexico, Peru, Venezuela, Costa Rica etc.), GCC, etc.

About Us

Accredited Consultancy provides exceptional value to the clients by rendering top-quality; cost-effective, customized, innovative, and timely drug regulatory services. We take responsibility and accountability for project performance, and strive to create a solution-based relationship. We are identified as one of the reliable providers of Drug Regulatory related Services, Custom Duty &Freight Forwarding that are appreciated by our national as well as international clients. ACPL currently has clients in the United Kingdom, Republic of china and the United States of America and has provided technical guidance to them. Clients' projects have ranged from import to registration to new chemical entity registration to clinical phase. Various qualified personnel are appointed in to provide maximum benefit to the clients for availing Custom Duty &Freight Forwarding and Drug Regulatory Services. We also provide regulatory consulting services to pharmaceutical, medical device, biotech, and other medical companies to help them expand and retain their presence in the Indian markets.

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Our Clients