Top Rated Business Consultant Company in India

We are doing works in all sections of the Drug Department being we are working for varied manufacturers & importers needless to mention about clinical trial permissions & import permits coupled with related departments such as DGFT, Animal Husbandry, Ministry of Science & Technology etc. To pinpoint, we work for several multinationals & we are even guiding many companies in preparing dossiers. You can consult us even before hand in case of any doubt in preparing the application.  In other words we claim that our basis of consultancy is knowledge and that makes us a different consultant. We attempt to nurture & exploit the maximum possibilities of the law relating to the same. We generally look at the drug regulatory by the angle of custom’s laws to avoid future complicacies. We work professionally & not as an individual doing liaison, which is the common scenario otherwise. We believe in doing of works with knowledge and according to standards of Industry. We ensure 100% compliance with the laws of the land and other International laws like FCPA. We are professional company having good infrastructure, therefore, we are capable of doing things differently which is the basis and secret of our success in the Drug Regulatory Consultancy.

We are one of the companies which has the largest number of briefs on Diagnostics & Medical Devices Regulatory, hence our experience is vast.  We too help in preparing Dossiers for obtaining Manufacturing Licenses, GMP etc, from respective State Drug Controller & Regional CDSCO.

We are into consultancy of getting accreditation such as NABH to hospitals, NABL to laboratories & other accreditation in the field of healthcare in various countries.

We have channel partners in the field of various consultancy & we are associated with other consultancy services. We help our esteemed clients and foreign companies to establish in India by providing the services of relevant professionals like  a Company Secretary, a Chartered Accountant (Audit & Accounting works), a professional doing Market Study & other relevant works, a professional organization doing clinical trials, HR Consultants, CE Certification Consultant, ISO Accreditation Consultants and such other professionals as per requirement.

OUR AREA OF SERVICES

Special NOC’s/Approvals/Permissions/Waivers

Testing: Form 11,NOCs

Import Licenses, Registration

Dual Use NOC for drug (bulk and finished form), cosmetics, medical devices and kits

Change of Location

Renewal of Licenses/Extensions, Recertification

Documentation and Preparation of Dossier

Submissions at Regulatory Govt Offices in State FDA, CDSCO-Central, Zonal and Sub Zonal Offices,

DGFT, CDL/CDTL, NABL Testing’s

Submission of Govt fee for various Licenses, NOCs and Permissions

Submission, Meetings and Collection of Test Reports from Govt Labs Example NABL,CDTL/CDL etc

Technical and Regulatory Support for queries by Port Officers

Regulatory Consultancy: Related to matters of State Drug Control Offices, CDSCO-HQ Zonal and Sub Zonal Offices

Custom Regulatory Services

Wireless Products Permission from MOT

Permission from MOE, MOA, CIB, BIS

Others

Pharmacovigilance Services:

Strategic and operational benefit/risk safety services. We are provided the complete solutions for Pharmacovigilance as per regulatory requirement. ACPL is globally providing the full range of Pharmacovigilance services.

Management of case reports and adverse event reporting Individual Case Safety Report (ICSRs) Processing

Post‐Marketing Non‐Solicited/Spontaneous Reports

 

Clinical trial Reports:

Special Reports: Pregnancy reports etc.

Medical Device related Reports

Routine safety surveillance, signal detection and Management

Risk-benefit management and analysis

Risk Management Plans (RMPs)

Qualified Person for Pharmacovigilance (QPPV)

Aggregate/Periodic Report Writing & Submission (PSURs/PBRERs/PADERs/DSURs), IND annual safety reports etc.

Medical Writing Services/ Clinical & Regulatory Writing Services:

We provide Medical Writing Services entails the generation of well‐structured individual reports supporting Extensive medical writing programs, including

Aggregate & Periodic Report Writing (PSURs/PBRERs/PADERs/DSURs) & Submission

Pharmaceutical Risk Management Plans (RMPs)

SAE Narratives for Clinical Study Reports

Clinical Study Reports

Clinical Summaries/Product Feasibility Reports for Medical Devices

Annual safety report writing

Patient Diary Cards (PDC), Informed Consent Form (ICF), Case Report Forms (CRFs) etc.

Company Core Safety Information (CCSI), Company Core Data Sheet (CCDS), Summary of Product Characteristics (SmPC), Pack Insert and Local Labels

Detailed Description of Pharmacovigilance Systems (DDPS)

Literature and Brochure for medical devices

Proficiency in creating detailed NDA, ANDA and IND applications (Module 1 ,2,3,4 and 5)

Manufacturing License for Allopathic Drugs, Medical Devices and Cosmetics.

Manufacturing License/Loan License/Form 29

GMP/WHO GMP Certificate

Export NOCs

Free Sale Certificate

Neutral Code Certificate

Advance License

Site Audits

Renewal of Licenses, Certificates

R&D Recognition from DSIR

Legalization from Embassy & Notarization(Whenever Required)

Insecticide License/Pesticide License

Seeds License

Fertilizer License

Food License

Tread Mark

Patent

Copyright

Shop Establishment

Tread License

Labor License

PF and ESI Registration

Pollution NOC and License

Fire License

Corporate Contracts.

Employment Contracts

Others

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